Walter Lorenz Surgical, Inc 01-50-1000

1520 Tradeport Drive FORM Y-PKG-114

Jacksonville, FL 32218-2480 Date: 7-29-02

P.O. Box 18009

Jacksonville, FL 32229-8009

**TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM**

**Essential Prescribing Information (EPI)**

**DESCRIPTION:**

# The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. DO NOT USE THE INDIVIDUAL COMPONENTS FOR PARTIAL JOINT RECONSTRUCTION.

# 

# MATERIALS:

# Mandibular Component -- Cobalt-Chromium-Molydenum (Co-Cr-Mo) alloy with titanium alloy 

#  coating 

# Fossa Component -- UHMWPE

# Screws -- Titanium alloy

**INDICATIONS:**

The Total TMJ Replacement System is indicated for use in cases of:

1.  arthritic conditions: osteoarthritis, rheumatoid arthritis, or
    traumatic arthritis

2.  malignancy (e.g. post-tumor excision)

3.  benign neoplasms

4.  functional deformity

5.  revision procedures where other treatments (e.g. alloplastic
    reconstruction, autogenous grafts) have failed

6.  avascular necrosis

7.  ankylosis including but not limited to recurrent ankylosis with
    excessive heterotopic bone formation

8.  degenerated or resorbed joints with severe anatomic discrepancies

9.  fracture

10. multiple operated joints

11. developmental abnormality

**CONTRAINDICATIONS:**

1.  Active or chronic infection.

2.  Patient conditions where there is insufficient quantity or quality
    of bone to support the components.

3.  Systemic disease with increased susceptibility to infection.

4.  Patients with extensive perforations in the mandibular fossa and/or
    bony deficiencies in the articular eminence or zygomatic arch that
    would severely comprise support for the artificial fossa component.

5.  Partial TMJ joint reconstruction.

6.  Known allergic reaction to any materials used in the components.

> NOTE: Patients with known or suspected nickel sensitivity should not
> have Co-Cr-Mo
>
> devices implanted since this material contains nickel.

7.  Patients with mental or neurological conditions who are unwilling or
    unable to follow

> postoperative care instructions.

8.  Skeletally immature patients.

9.  Patients with severe hyper-functional habits (e.g. clenching,
    grinding etc.)

**WARNINGS:**

The following risks are associated with the use of a total TMJ system.

1.  Implant loosening or displacement can occur.

2.  The screws used to anchor the implant may loosen causing changes in
    bite, difficulty in

chewing, limited joint function and/or unpredictable wear on implant
components.

3.  Implant breakdown may result in erosion or resorption of the glenoid
    fossa, which may result in intense pain.

4.  A foreign body reaction may occur resulting in implant deterioration
    and migration of

materials.

5\. If the implant is not properly sterilized, infection may result.

6.  If the implant materials are unable to withstand the forces or
    pressure placed on the implant,

the implant can be torn, worn, perforated, fragmented, fatigued, or
fractured resulting in

failure of the device to function properly.

7.  Degenerative changes within the joint surfaces and components of the
    TMJ due to implant

breakdown may result in chronic pain.

8.  Degenerative changes in the joint cartilage and/or bone from disease
    or previous implants

may lead to failure of this device.

9.  If the implant materials are subject to the production of particles
    or corrosion, toxic elements

may migrate to various parts of the body.

10. Placement of the implant in one joint only may result in harmful
    effects to the joint on the

opposite side.

11. Placement of the implant may produce an improper relationship
    between the teeth surfaces

that should contact during biting.

12. Implant breakdown may cause bony erosion, heterotopic bone
    formation, or reactive bone within the joint.

13. Use of implants may result in tinnitus or other ear problems.

14. Limited range of motion and chronic pain may continue after total
    TMJ surgery.

15. Infection which may result in implant removal.

16. Damage to the facial and/or trigeminal nerve with temporary or
    permanent paralysis of the facial muscle and/or loss of feeling in
    the chin, teeth, tongue, or lower jaw may occur.

The surgeon must be thoroughly knowledgeable with the components,
instruments and surgical procedure. In all cases sound medical practice
is to be followed and the surgeon must select the type of device
appropriate for treatment. Existing mandibular and/or zygomatic arch
screws or screw holes may compromise fixation. The Total TMJ Replacement
System is designed for total joint reconstruction and components are to
be used as a system. Do not use the individual components for partial
joint reconstruction.

The patient is to be warned that the system does not replace normal
healthy bone in their TMJ and they may continue to have chronic pain and
limited range of motion. The system can break or loosen as a result of
stress, activity, or trauma. Patients with severe hyper-functional
habits may have an undesirable outcome. The patient is to be made aware
of surgical risks and possible adverse effects prior to surgery and
warned that failure to follow postoperative care instructions can cause
failure of the implant and the treatment.

**PRECAUTIONS:**

1.  DO NOT USE if there is loss of sterility of the devices.

2.  DO NOT USE opened or damaged implants and only use implants that are
    packaged in unopened or undamaged containers.

3.  DO NOT USE the individual components of this total system (e.g.
    mandibular components, fossa components, or screws) for partial
    joint reconstruction.

4.  Infection can lead to failure and subsequent removal of the devices.

5.  Damage to the implant can occur as a result of traumatic injury or
    excessive activity.

6.  Neurovascular injuries can occur due to surgical trauma.

7.  Metal sensitivity or foreign body reaction can occur due to the
    device materials or materials from previously implanted devices.

8.  Implant breakdown and/or degenerative changes in the TMJ may cause
    pain, which may lead to re-operation.

9\. Use of the system with filler material:

The fossa component may be used with a filler material when it is
desired to fill

voids between the fossa prosthesis and the glenoid fossa bone. The
filler should never be

used for fixation of the device or in any load bearing application. If a
filler is used in the

fossa region, screws are placed after polymerization of the filling
material, if applicable. Use

of any legally marketed craniomaxillofacial filler material is
recommended.

###### INSTRUMENTATION PRECAUTIONS:

Specialized instruments are designed for use with the Total TMJ
Replacement System to aid in the accurate implantation of the
components. Intra-operative fracture or breakage of instruments can
occur. Instruments are subject to wear with normal usage. Instruments,
which have experienced extensive use or excessive force, are susceptible
to fracture. Surgical instruments should only be used for their intended
purpose. W. Lorenz recommends that all instruments be regularly
inspected for wear and disfigurement.

**ADVERSE EVENTS:**

Adverse events reported throughout the duration of an approved Food and
Drug Administration (FDA) clinical study implanting the Total TMJ
Replacement System are summarized as the following. See Tables 6 and 7
for more detailed information

• Removal of components(s)

• Infection (systemic or superficial)

• Facial swelling and/or pain

• Facial nerve dysfunction

• Excision of tissue

• Heterotopic bone formation

• Neuroma formation

• Ear problems

• Dislocation

**CLINICAL STUDIES:**

A prospective clinical study began in the United States in 1995 and was
designed to document patient outcomes after implantation of the Total
TMJ Replacement System. Unilateral and bilateral patients were enrolled
only after non-surgical treatment and/or previous implant failure.

A total of 180 cases received 268 joints. Overall patients demonstrated
decrease pain, increase function, increase in maximal incisal opening
(MIO), and satisfaction with their outcome. See the following Tables
1-7, which summarize the clinical outcome.

##### TABLE 1

#### Jaw Pain Intensity

<table>
<colgroup>
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><h3
id="visual-analog-scale-0-none-10-most-intense-pain-imaginable"><strong>Visual
Analog Scale (0 = none, 10 = most intense pain
imaginable)</strong></h3></td>
</tr>
<tr class="even">
<td>Jaw Pain</td>
<td>Pre-op n=180</td>
<td>1 mo. n=170</td>
<td>3 mo. n=153</td>
<td>6 mo. n=143</td>
<td>1 yr n=116</td>
<td>1.5 yr n=89</td>
<td>3 yrs n=45</td>
<td><p>4 yrs</p>
<p>n=22</p></td>
<td>5 yrs n=4</td>
<td><p>6 yrs</p>
<p>n=5</p></td>
</tr>
<tr class="odd">
<td><strong>Mean</strong></td>
<td><strong>8.1</strong></td>
<td><strong>4.3</strong></td>
<td><strong>3.6</strong></td>
<td><strong>3.1</strong></td>
<td><strong>2.9</strong></td>
<td><strong>3.4</strong></td>
<td><strong>2.6</strong></td>
<td><strong>3.2</strong></td>
<td><strong>2.6</strong></td>
<td><strong>2.9</strong></td>
</tr>
<tr class="even">
<td><h1 id="no-data">No data</h1></td>
<td>0</td>
<td>9</td>
<td>17</td>
<td>15</td>
<td>19</td>
<td>17</td>
<td>10</td>
<td>1</td>
<td>5</td>
<td>3</td>
</tr>
<tr class="odd">
<td><p>Death/</p>
<p>Removal</p></td>
<td>0</td>
<td>1</td>
<td>1</td>
<td>2</td>
<td>3</td>
<td>3</td>
<td>2</td>
<td>0</td>
<td>1</td>
<td>1</td>
</tr>
<tr class="even">
<td>Total n possible</td>
<td>180</td>
<td>180</td>
<td>171</td>
<td>160</td>
<td>138</td>
<td>109</td>
<td>57</td>
<td>23</td>
<td>10</td>
<td>9</td>
</tr>
</tbody>
</table>

**[TABLE 2]{.underline}**

***Interference with Eating***

<table style="width:100%;">
<colgroup>
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><h3 id="visual-analog-scale-0-none-10-excruciating">
<strong>Visual Analog Scale (0 = none, 10 =
excruciating)</strong></h3></td>
</tr>
<tr class="even">
<td>Interference with Eating</td>
<td>Pre-op n=180</td>
<td>1 mo. n=170</td>
<td>3 mo. n=153</td>
<td>6 mo. n=143</td>
<td>1 yr n=116</td>
<td>1.5 yr n=89</td>
<td><p>3 yrs</p>
<p>n=45</p></td>
<td>4 yrs n=22</td>
<td>5 yrs n=4</td>
<td><p>6 yrs</p>
<p>n=5</p></td>
</tr>
<tr class="odd">
<td><strong>Mean</strong></td>
<td><strong>8.0</strong></td>
<td><strong>4.5</strong></td>
<td><strong>3.4</strong></td>
<td><strong>3.0</strong></td>
<td><strong>2.8</strong></td>
<td><strong>3.0</strong></td>
<td><strong>2.5</strong></td>
<td><strong>3.5</strong></td>
<td><strong>3.2</strong></td>
<td><strong>3.0</strong></td>
</tr>
<tr class="even">
<td>No data</td>
<td>0</td>
<td>9</td>
<td>17</td>
<td>15</td>
<td>19</td>
<td>17</td>
<td>10</td>
<td>1</td>
<td>5</td>
<td>3</td>
</tr>
<tr class="odd">
<td><p>Death/</p>
<p>Removal</p></td>
<td>0</td>
<td>1</td>
<td>1</td>
<td>2</td>
<td>3</td>
<td>3</td>
<td>2</td>
<td>0</td>
<td>1</td>
<td>1</td>
</tr>
<tr class="even">
<td>Total n possible</td>
<td>180</td>
<td>180</td>
<td>171</td>
<td>160</td>
<td>138</td>
<td>109</td>
<td>57</td>
<td>23</td>
<td>10</td>
<td>9</td>
</tr>
</tbody>
</table>

**[TABLE 3]{.underline}**

***Maximal Incisal Opening (MIO***)

<table style="width:100%;">
<colgroup>
<col style="width: 12%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="11"><h3 id="measured-in-millimeters-mm"> <strong>Measured
in millimeters (mm)</strong></h3></td>
</tr>
<tr class="even">
<td>MIO</td>
<td>Pre-op n=180</td>
<td>1 mo. n=170</td>
<td>3 mo. n=153</td>
<td>6 mo. n=143</td>
<td>1 yr n=116</td>
<td>1.5 yr n=89</td>
<td>3 yrs n=45</td>
<td><p>4 yrs</p>
<p>n=22</p></td>
<td>5 yrs n=4</td>
<td><p>6 yrs</p>
<p>n=5</p></td>
</tr>
<tr class="odd">
<td><strong>Mean</strong></td>
<td><strong>19.2</strong></td>
<td><strong>25.0</strong></td>
<td><strong>29.2</strong></td>
<td><strong>30.1</strong></td>
<td><strong>30.7</strong></td>
<td><strong>30.7</strong></td>
<td><strong>29.8</strong></td>
<td><strong>30.3</strong></td>
<td><strong>28.5</strong></td>
<td><strong>26.6</strong></td>
</tr>
<tr class="even">
<td>No data</td>
<td>0</td>
<td>9</td>
<td>17</td>
<td>15</td>
<td>19</td>
<td>17</td>
<td>10</td>
<td>1</td>
<td>5</td>
<td>4</td>
</tr>
<tr class="odd">
<td><p>Death/</p>
<p>Removal</p></td>
<td>0</td>
<td>1</td>
<td>1</td>
<td>2</td>
<td>3</td>
<td>3</td>
<td>2</td>
<td>0</td>
<td>1</td>
<td>1</td>
</tr>
<tr class="even">
<td>Total n possible</td>
<td>180</td>
<td>180</td>
<td>171</td>
<td>160</td>
<td>138</td>
<td>109</td>
<td>57</td>
<td>23</td>
<td>10</td>
<td>9</td>
</tr>
</tbody>
</table>

**[TABLE 4]{.underline}**

***Patient Satisfaction (\* includes enthusiastic, very satisfied, and
satisfied)***

<table>
<colgroup>
<col style="width: 13%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td>% of joints</td>
<td>1 mo. n=236</td>
<td>3 mo. n=212</td>
<td>6 mo. n=193</td>
<td>1 yr n=156</td>
<td>1.5 yr n=119</td>
<td><p>3 yrs</p>
<p>n=58</p></td>
<td>4 yrs n=25</td>
<td>5 yrs n=5</td>
<td><p>6 yrs</p>
<p>n=8</p></td>
</tr>
<tr class="even">
<td><p><strong>Satisfied*</strong></p>
<p><strong>Or better</strong></p></td>
<td><strong>97%</strong></td>
<td><strong>95%</strong></td>
<td><strong>95%</strong></td>
<td><strong>96%</strong></td>
<td><strong>97%</strong></td>
<td><strong>98%</strong></td>
<td><strong>100%</strong></td>
<td><strong>100%</strong></td>
<td><strong>100%</strong></td>
</tr>
<tr class="odd">
<td>No data</td>
<td>11</td>
<td>25</td>
<td>20</td>
<td>17</td>
<td>21</td>
<td>9</td>
<td>3</td>
<td>8</td>
<td>4</td>
</tr>
<tr class="even">
<td><p>Death/</p>
<p>Removal</p></td>
<td>1</td>
<td>1</td>
<td>3</td>
<td>3</td>
<td>4</td>
<td>2</td>
<td>1</td>
<td>0</td>
<td>1</td>
</tr>
<tr class="odd">
<td>Total n possible</td>
<td>248</td>
<td>238</td>
<td>216</td>
<td>176</td>
<td>144</td>
<td>69</td>
<td>29</td>
<td>13</td>
<td>13</td>
</tr>
</tbody>
</table>

**[Table 5]{.underline}**

In Hindsight, Would You Choose to Have This Surgery?

<table>
<colgroup>
<col style="width: 11%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 9%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
<col style="width: 10%" />
</colgroup>
<tbody>
<tr class="odd">
<td>% of patients</td>
<td>1 mo. n=170</td>
<td>3 mo. n=153</td>
<td>6 mo. n=143</td>
<td>1 year n=116</td>
<td>1.5 year n=89</td>
<td>3 years n=45</td>
<td><p>4 years</p>
<p>n=22</p></td>
<td>5 years n=4</td>
<td><p>6 years</p>
<p>n=5</p></td>
</tr>
<tr class="even">
<td><h1 id="yes"><strong>Yes</strong></h1>
<p><strong>%</strong></p></td>
<td><p>168</p>
<p><strong>99%</strong></p></td>
<td><p>148</p>
<p><strong>97%</strong></p></td>
<td><p>140</p>
<p><strong>98%</strong></p></td>
<td><p>112</p>
<p><strong>97%</strong></p></td>
<td><p>84</p>
<p><strong>95%</strong></p></td>
<td><p>44</p>
<p><strong>98%</strong></p></td>
<td><p>20</p>
<p><strong>91%</strong></p></td>
<td><p>4</p>
<p><strong>100%</strong></p></td>
<td><p>5</p>
<p><strong>100%</strong></p></td>
</tr>
<tr class="odd">
<td><h1 id="unsure">Unsure</h1></td>
<td>0</td>
<td>0</td>
<td>0</td>
<td>0</td>
<td>0</td>
<td>1</td>
<td>0</td>
<td>0</td>
<td>0</td>
</tr>
<tr class="even">
<td><h1 id="no-data-1">No data</h1></td>
<td>9</td>
<td>17</td>
<td>15</td>
<td>19</td>
<td>17</td>
<td>10</td>
<td>1</td>
<td>5</td>
<td>4</td>
</tr>
<tr class="odd">
<td>LTF<sup>1</sup></td>
<td>1</td>
<td>1</td>
<td>2</td>
<td>3</td>
<td>3</td>
<td>2</td>
<td>0</td>
<td>1</td>
<td>1</td>
</tr>
<tr class="even">
<td>Total n possible</td>
<td>180</td>
<td>171</td>
<td>160</td>
<td>138</td>
<td>109</td>
<td>57</td>
<td>23</td>
<td>10</td>
<td>9</td>
</tr>
</tbody>
</table>

^1^ LTF = Lost to follow-up (either death or permanent removal of all
components)

##### [Table 6]{.mark}

***[Adverse Events]{.mark}*** Requiring Device Removal

+-------------------------------------------+------------+------------+
| []{.mark}                                 | [**Cases** | [          |
|                                           | (n=18      | **Joints** |
|                                           | 0)]{.mark} | (n=26      |
|                                           |            | 8)]{.mark} |
|                                           | [\#        |            |
|                                           | %]{.mark}  | [\#        |
|                                           |            | %]{.mark}  |
+-------------------------------------------+------------+------------+
| 1.  **[Permanent removal of fossa         | [4 2.2     | [4 1.5     |
|     component:]{.mark}**                  | %]{.mark}  | %]{.mark}  |
|                                           |            |            |
| ```{=html}                                | []{.mark}  | []{.mark}  |
| <!-- -->                                  |            |            |
| ```                                       | []{.mark}  | []{.mark}  |
| a.  [One due to aseptic necrosis]{.mark}  |            |            |
|                                           |            | []{.mark}  |
| b.  [Two due to infection]{.mark}         |            |            |
|                                           |            |            |
| c.  [One due to swelling]{.mark}          |            |            |
+-------------------------------------------+------------+------------+
| 2.  [**Removal (non-permanent)**^1^ **of  | [4 2.2     | [5 1.9     |
|     mandibular component: **]{.mark}      | %]{.mark}  | %]{.mark}  |
|                                           |            |            |
| ```{=html}                                | []{.mark}  | []{.mark}  |
| <!-- -->                                  |            |            |
| ```                                       | []{.mark}  | []{.mark}  |
| a.  [Two bilateral removals of            |            |            |
|     heterotopic bone]{.mark}              | []{.mark}  | []{.mark}  |
|                                           |            |            |
| b.  [One re-positioning of mandibular     |            | []{.mark}  |
|     component]{.mark}                     |            |            |
|                                           |            |            |
| > [due to asymmetry of mandible]{.mark}   |            |            |
+-------------------------------------------+------------+------------+
| 3.  **[Permanent removal of mandibular    | [1         | [1         |
|     component:]{.mark}**                  | 0.         | 0.         |
|                                           | 6%]{.mark} | 4%]{.mark} |
| ```{=html}                                |            |            |
| <!-- -->                                  |            |            |
| ```                                       |            |            |
| a.  [Larger component causing a           |            |            |
|     dislocation]{.mark}                   |            |            |
|                                           |            |            |
| > [removed and replaced with smaller      |            |            |
| > component]{.mark}                       |            |            |
+-------------------------------------------+------------+------------+
| 4.  **[Permanent removal of total         | [6 3.3     | [7 2.6     |
|     joint:]{.mark}**                      | %]{.mark}  | %]{.mark}  |
|                                           |            |            |
| ```{=html}                                | []{.mark}  |            |
| <!-- -->                                  |            |            |
| ```                                       | []{.mark}  |            |
| a.  [One unilateral patient requested     |            |            |
|     removal due to pain and swelling      |            |            |
|     after 6 months]{.mark}                |            |            |
|                                           |            |            |
| b.  [Four removals due to                 |            |            |
|     infection]{.mark}                     |            |            |
|                                           |            |            |
| c.  [One bilateral removal due to         |            |            |
|     re-ankylosis]{.mark}                  |            |            |
+-------------------------------------------+------------+------------+
| [ Permanent removal]{.mark}               | [11 6.1    | [12 4.5    |
|                                           | %]{.mark}  | %]{.mark}  |
| #  [Non-permanent removal]{.mark}         |            |            |
|                                           | [4 2.2     | > [5 1.9   |
| [ ]{.mark}                                | %]{.mark}  | >          |
|                                           |            |  %]{.mark} |
| [**TOTAL**]{.mark}                        | []{.mark}  |            |
|                                           |            | []{.mark}  |
|                                           | [**15 8.3  |            |
|                                           | %          | [**17      |
|                                           | **]{.mark} | 6.3%       |
|                                           |            | **]{.mark} |
+-------------------------------------------+------------+------------+

[^1^ Mandibular components were taken out in the operating room for
removal of heterotopic bone or re-positioning]{.mark}

[and then were placed back in the joint.]{.mark}

##### [Table 7]{.mark}

Adverse Events Not Requiring Device Removal

+-------------------------------------+-----------------+-------------+
| **[Adverse Events]{.mark}**         | # [**Cases**    | [**Joints** |
|                                     | (n=180)]{.mark} | (n=2        |
|                                     |                 | 68)]{.mark} |
|                                     | [\# %]{.mark}   |             |
|                                     |                 | [\#         |
|                                     |                 | %]{.mark}   |
+-------------------------------------+-----------------+-------------+
| [Reflex Sympathetic Dystrophy       | [1 0.6]{.mark}  | [1          |
| (RSD)]{.mark}                       |                 | 0.4]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Facial nerve dysfunction]{.mark}   | [1 0.6]{.mark}  | [1          |
|                                     |                 | 0.4]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Excision of tissue]{.mark}         | [5 (11) 2.8     | [6          |
|                                     | (6.1)]{.mark}   | 2.2]{.mark} |
| [(excluding neuroma and/or          |                 |             |
| heterotopic bone)]{.mark}           |                 |             |
+-------------------------------------+-----------------+-------------+
| [Heterotopic bone excision]{.mark}  | [2 (3) 1.1      | [4          |
|                                     | (1.7)]{.mark}   | 1.5]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Chronic severe masseter muscle     | [3 1.7]{.mark}  | [4          |
| spasms]{.mark}                      |                 | 1.5]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Lump at cervical incision]{.mark}  | [1 0.6]{.mark}  | [1          |
|                                     |                 | 0.4]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Motor vehicle accident             | [9 5.0]{.mark}  | [15         |
| (MVA)]{.mark}                       |                 | 5.6]{.mark} |
|                                     |                 |             |
| [- increased pain regardless of     |                 |             |
| facial impact]{.mark}               |                 |             |
+-------------------------------------+-----------------+-------------+
| [Facial trauma (excluding           | [5 2.8]{.mark}  | [6          |
| MVA)]{.mark}                        |                 | 2.2]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Head trauma with no jaw            | [1 0.6]{.mark}  | [2          |
| involvement]{.mark}                 |                 | 0.7]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Neuroma excision]{.mark}           | [6 (7) 3.3      | [ 7         |
|                                     | (3.9)]{.mark}   | 2.6]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Death (all unrelated)]{.mark}      | [3 1.7]{.mark}  | [3          |
|                                     |                 | 1.1]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Fever of unknown origin with       | [1 0.6]{.mark}  | [2          |
| facial swelling]{.mark}             |                 | 0.7]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Coronoidectomy]{.mark}             | [9 5.0]{.mark}  | [15         |
|                                     |                 | 5.6]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Manipulation of mandible under     | [1 0.6]{.mark}  | [1          |
| general anesthesia]{.mark}          |                 | 0.4]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Unrelated disease diagnosis        | [3 1.7]{.mark}  | [5          |
| (multiple sclerosis,]{.mark}        |                 | 1.9]{.mark} |
|                                     |                 |             |
| [Multiple myeloma,                  |                 |             |
| meningitis)]{.mark}                 |                 |             |
+-------------------------------------+-----------------+-------------+
| [Abscess                            | [4 2.2]{.mark}  | [ 7         |
| (stitch/facial/intraoral)]{.mark}   |                 | 2.6]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Skin infection (not in area of     | [2 1.1]{.mark}  | [3          |
| prosthesis)]{.mark}                 |                 | 1.1]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Dislocation (mandible)]{.mark}     | [3 1.7]{.mark}  | [5          |
|                                     |                 | 1.9]{.mark} |
+-------------------------------------+-----------------+-------------+
| [Ear infection]{.mark}              | [4 (6) 2.2      | [5          |
|                                     | (3.3)]{.mark}   | 1.9]{.mark} |
| [(two with tympanic membrane        |                 |             |
| perforation)]{.mark}                | []{.mark}       | []{.mark}   |
+-------------------------------------+-----------------+-------------+
| [External ear canal                 | [2 1.1]{.mark}  | [2          |
| problems:]{.mark}                   |                 | 0.7]{.mark} |
|                                     |                 |             |
| 1.  [Perforation]{.mark}            |                 |             |
|                                     |                 |             |
| 2.  [Granulation formation]{.mark}  |                 |             |
+-------------------------------------+-----------------+-------------+
| [Scalp alopecia from anesthesia     | [1 0.6]{.mark}  | [2          |
| tubing pressure]{.mark}             |                 | 0.7]{.mark} |
+-------------------------------------+-----------------+-------------+
| [**TOTAL**]{.mark}                  | [**67           | [**97       |
|                                     | 37.2**]{.mark}  | 36.         |
|                                     |                 | 2**]{.mark} |
+-------------------------------------+-----------------+-------------+

[**\*** These numbers in parenthesis ( ) are the incidence.]{.mark}

**INDIVIDUALIZATION OF TREATMENT:**

*Do not use in children.* The Total TMJ Replacement was designed for use
in skeletally mature patients.

**PATIENT COUNSELING INFORMATION:**

Discussion of the following points is recommended prior to surgery.

• The importance of prompt medical attention if they experience unusual
swelling in the area of

the implant.

• The risks associated with a total TMJ system (see Warnings and Adverse
Events).

• Post-operative pain relief and return of function varies from patient
to patient.

• Additional treatment may be required including but not limited to
extended physical therapy,

bite splint, dental braces, and/or orthognathic and reconstructive
surgery .

**HOW SUPPLIED:**

The Total TMJ Replacement System mandibular and fossa components are
supplied sterile in individual packages. Screws, trials, and instruments
are supplied non-sterile and must be sterilized prior to surgical use.
See the following autoclave recommendations under Sterility.

**INSTRUCTIONS FOR USE:**

A detailed Surgical Technique is available describing implantation of
the components.

## REUSABLE INSTRUMENT CLEANING METHOD

1.  [Disassemble]{.underline} reusable instruments from powered hand
    piece (powered hand pieces not supplied by Lorenz). Clean reusable
    instruments within two hours after being used in surgical
    application.

> 2\. [Pre-clean]{.underline}
>
> Remove gross contamination by hand under running water using a
> mechanical aid (e.g.
>
> brush). Wear protective gloves and goggles.
>
> 3\. [Pre-wash Cycle]{.underline}
>
> After visually removing gross contamination, clean using an automatic
> washer unit using
>
> a thermal ultrasonic cycle or a continuous tunnel process. Automatic
> washer equipment
>
> should be operated as instructed by the manufacturer of the washer
> unit.
>
> Minimum cycle parameters: 4 minutes at 49^o^ C or 120 ^o^ F
>
> 4\. [Wash Cycle]{.underline}
>
> Use detergent per manufacturer's instructions.
>
> Minimum cycle parameters: 12 minutes at 49^o^ C or 120 ^o^ F

5\. [Final Rinse]{.underline}

#  After washing, reusable instruments are rinsed with deionized water for a minimum of 4 

#  minutes at 49^o^ C or 120 ^o^ F. Reusable instruments should be placed in the instrument 

#  tray. 

> Warning: Do not reuse titanium screws under any condition. Discard
> screws that were applied to the patient and removed. Do not reuse
> screws that entered the operative site.

**STERILITY:**

The Total Temporomandibular Joint Replacement System mandibular and
fossa components are sterilized by exposure to a minimum of 25 kGy of
gamma irradiation. DO NOT RESTERILIZE.

**Screws, trials, and instruments are supplied non-sterile.**

*The following autoclave recommendations are for sterilization of
screws, trials, instruments, and containers used with the Total TMJ
Replacement System.*

[Pre-Vacuum Steam Sterilization:]{.underline}

Temperature: 270º - 275º F (133º - 135º C)

#  Time: Fifteen (15 minutes 

Drying Time: Eight (8) minutes

Since Walter Lorenz Surgical, Inc. is not familiar with individual
handling methods, cleaning

methods and bioburden, Walter Lorenz Surgical, Inc. cannot assume
responsibility for

sterility even when the above guidelines are followed.

**CAUTION:**

Federal Law (USA) restricts this device to sale, distribution, or use,
by or on the order of a physician.

Authorized Representative:

Biomet Merck

Waterton Industrial Estates

Bridgend, South Wales

321CF 3AX, U.K.

![](media/image1.wmf){width="0.2923611111111111in"
height="0.24791666666666667in"} 0086