Study: NCT03589300

Adverse event: Cellulitis/Redness/Blistering
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Contralateral Knee Replacement (UKA or TKA)
Serious: yes
Organ System: Surgical and medical procedures
Notes: General adverse event (not study knee)
Frequency: 3 affected / 125 at risk

Adverse event: Deep Wound Infection
Serious: yes
Organ System: Infections and infestations
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Effusion/Swelling/Edema
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Endocrine
Serious: yes
Organ System: Endocrine disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 125 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 125 at risk

Adverse event: Hematological/Abnormal Lab
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: General adverse event (not study knee)
Frequency: 1 affected / 125 at risk

Adverse event: Infection (not study knee)
Serious: yes
Organ System: Infections and infestations
Notes: General adverse event (not study knee)
Frequency: 1 affected / 125 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: 5 affected / 125 at risk

Adverse event: Pain (progressive/persistent)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 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: 3 affected / 125 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Notes: General adverse event (not study knee)
Frequency: 6 affected / 125 at risk

Adverse event: Cellulitis/Redness/Blistering
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Clicking/Popping/Crepitus/Grinding
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 4 affected / 125 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: 6 affected / 125 at risk

Adverse event: Deep Wound Infection
Serious: no
Organ System: Infections and infestations
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 125 at risk

Adverse event: Effusion/Swelling/Edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Endocrine
Serious: no
Organ System: Endocrine disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 125 at risk

Adverse event: Femoral Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 125 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 125 at risk

Adverse event: Genitourinary/Renal
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 125 at risk

Adverse event: Hematological/Abnormal Lab
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: General adverse event (not study knee)
Frequency: 3 affected / 125 at risk

Adverse event: Infection (not study knee)
Serious: no
Organ System: Infections and infestations
Notes: General adverse event (not study knee)
Frequency: 2 affected / 125 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: 31 affected / 125 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Notes: General adverse event (not study knee)
Frequency: 4 affected / 125 at risk

Adverse event: Other General Adverse Event
Serious: no
Organ System: General disorders
Notes: General adverse event (not study knee)
Frequency: 5 affected / 125 at risk

Adverse event: Other Ipsilateral Knee Related Adverse Event
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 3 affected / 125 at risk

Adverse event: Pain (progressive/persistent)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 13 affected / 125 at risk

Adverse event: Patellar Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Notes: General adverse event (not study knee)
Frequency: 2 affected / 125 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 / 125 at risk

Adverse event: Stiffness/Limited ROM (progress/persistent)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Study knee related
Frequency: 10 affected / 125 at risk

Adverse event: Traumatic Injury (not study knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: General adverse event (not study knee)
Frequency: 3 affected / 125 at risk

Adverse event: Traumatic Injury (study knee)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study knee related
Frequency: 3 affected / 125 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Study knee related
Frequency: 1 affected / 125 at risk