Study: NCT03272373

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Genitourinary/Renal
Serious: yes
Organ System: Renal and urinary disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Musculoskeletal (not study knee)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 104 at risk

Adverse event: Traumatic Injury (not study knee)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Deep Wound Infection
Serious: yes
Organ System: Infections and infestations
Notes: Study knee related
Frequency: 2 affected / 104 at risk

Adverse event: Other General Adverse Event
Serious: yes
Organ System: General disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 104 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: General adverse event (not study knee)
Frequency: 5 affected / 104 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: General adverse event (not study knee)
Frequency: 2 affected / 104 at risk

Adverse event: Oncological
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: General adverse event (not study knee)
Frequency: 2 affected / 104 at risk

Adverse event: Pulmonary/Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: General adverse event (not study knee)
Frequency: 2 affected / 104 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: no
Organ System: Surgical and medical procedures
Notes: General adverse event (not study knee)
Frequency: 3 affected / 104 at risk

Adverse event: Vascular/DVT
Serious: no
Organ System: Vascular disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 104 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Stiffness/Limited ROM (progressive/persistent)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 2 affected / 104 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 104 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 2 affected / 104 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 1 affected / 104 at risk

Adverse event: Pain (progressive/persistent)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 4 affected / 104 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 1 affected / 104 at risk

Adverse event: Cellulitis/Redness/Blistering
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 2 affected / 104 at risk

Adverse event: Traumatic Injury (study knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study knee related
Frequency: 2 affected / 104 at risk

Adverse event: Infection (not study knee)
Serious: no
Organ System: Infections and infestations
Notes: General adverse event (not study knee)
Frequency: 3 affected / 104 at risk

Adverse event: Other General Adverse Event
Serious: no
Organ System: General disorders
Notes: General adverse event (not study knee)
Frequency: 4 affected / 104 at risk

Adverse event: Musculoskeletal (not study knee)*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General adverse event (not study knee)
Frequency: 16 affected / 104 at risk

Adverse event: Other Ipsilateral Knee Related Adverse Event
Serious: no
Organ System: General disorders
Notes: Study knee related
Frequency: 2 affected / 104 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 56 at risk

Adverse event: Musculoskeletal (not study knee)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 56 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 56 at risk

Adverse event: Pulmonary/Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 56 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 56 at risk

Adverse event: Pulmonary/Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 56 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: no
Organ System: Surgical and medical procedures
Notes: General adverse event (not study knee)
Frequency: 5 affected / 56 at risk

Adverse event: Vascular/DVT
Serious: no
Organ System: Vascular disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 56 at risk

Adverse event: Stiffness/Limited ROM (progressive/persistent)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 2 affected / 56 at risk

Adverse event: Clicking/Popping/Crepitus/Grinding
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 4 affected / 56 at risk

Adverse event: Pain (progressive/persistent)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 9 affected / 56 at risk

Adverse event: Articular Surface Dislocation/Disassociation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 1 affected / 56 at risk

Adverse event: Cellulitis/Redness/Blistering
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 1 affected / 56 at risk

Adverse event: Effusion/Swelling/Edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 3 affected / 56 at risk

Adverse event: Traumatic Injury (study knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study knee related
Frequency: 3 affected / 56 at risk

Adverse event: Musculoskeletal (not study knee)*
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: General adverse event (not study knee)
Frequency: 12 affected / 56 at risk