Study: NCT02983292

Adverse event: Right shoulder rotator cuff pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Right shoulder pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 137 at risk

Adverse event: Duke C Colon Cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Urosepsis following surgery for prostate cancer biopsy
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Meniscus tear in left knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: cancerous nodule thyroid
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Locking right knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Fractured left scaphoid following a fall.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: worsening OA left knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Worsening of OA in right knee
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Back pain exacerbated
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Deterioration of left shoulder secondary to pre-existing condition (avacular necrosis).
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Thoracic outlet syndrome progression
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Right shoulder rotator cuff impingement
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Right shoulder posterior instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Joint metallosis in right (operative) shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: Right shoulder OA worsening
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Cardiac chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Aggravation of OA in left thumb and wrist
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Persistent right rotator cuff pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Anterior shoulder pain due to subscap impingement on the anterior aspect of the hemiarthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Fracture of PyroTITAN prosthesis.
Serious: yes
Organ System: Product Issues
Notes: Device related
Frequency: 1 affected / 137 at risk

Adverse event: Cellulitis and recurring infection in right knee
Serious: yes
Organ System: Infections and infestations
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Left shoulder rotator cuff tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Broken right ankle
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Undisplaced fracture of implant
Serious: yes
Organ System: Product Issues
Notes: Device related
Frequency: 1 affected / 137 at risk

Adverse event: Worsening of OA in left shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Worsening knee OA and pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Difficulty with function and ROM in left operative shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Ongoing pain in left shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Right subscapular bursa irritation.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Procedure Related
Frequency: 1 affected / 137 at risk

Adverse event: Right shoulder full thickness tear
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Right leg cellulitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Rotator cuff tendonitis left shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Exacerbation of OA in right shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Exacerabated right shoulder OA.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Cellulitis in left leg.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Knife injury to left arm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Thoracic outlet syndrome progression.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Rotator cuff impingement left shoulder.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: worsening osteoarthritis left wrist
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Exacerbation of OA right knee.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Subscapular bursa irritation left shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Procedure Related
Frequency: 1 affected / 137 at risk

Adverse event: Fractured prosthesis
Serious: yes
Organ System: Product Issues
Notes: Device related
Frequency: 1 affected / 137 at risk

Adverse event: Worsening left shoulder osteoartritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Ongoing pain in right operative shoulder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: worsening Osteoarthritis in right foot
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Worsening left shoulder osteoarthritis.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Worsening right shoulder arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Worsenning osteoarthritis bilateral knees.
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Exacerbation of lower back nerve pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not related to Procedure or Device
Frequency: 1 affected / 137 at risk

Adverse event: Infection left shoulder wound
Serious: yes
Organ System: Infections and infestations
Notes: Procedure Related
Frequency: 1 affected / 137 at risk

Adverse event: Minor rotator cuff tendonitis left shoulder.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: Suspected stress fracture of posterior glenoid osteophyte right shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: Bursitis right shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: Squeaking right shoulder after physiotherapy.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure or device
Frequency: 1 affected / 137 at risk

Adverse event: Cuff pain right shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: Suspected rotator cuff tendonitis left shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not relate to procedure or device
Frequency: 1 affected / 137 at risk

Adverse event: Suspected rotator cuff tendonitis right.
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: Crepitation around right shoulder joint with activity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to Device
Frequency: 1 affected / 137 at risk

Adverse event: Occasional pain up right arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure or device
Frequency: 1 affected / 137 at risk

Adverse event: Audible squeaking left pyrotitan shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 137 at risk

Adverse event: Audible squeak on flexion/extension of operative shoulder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Device related
Frequency: 1 affected / 137 at risk

Adverse event: Persistent operative shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure or device
Frequency: 1 affected / 137 at risk

Adverse event: Skin irritation of scar in operative shoulder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Possibly related to procedure
Frequency: 1 affected / 137 at risk

Adverse event: right shoulder stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related to procedure or device
Frequency: 1 affected / 137 at risk