Table A1.
Participant ID | Adverse Event | Severity | Involves Operative Site/Hip | Relationship to study device |
---|---|---|---|---|
001 | Intraoperative fractured calcar of left femur | Mild | Yes | Definitely related |
Elective TKA | Mild | No | Not related | |
First Seizure | Mild | No | Not related | |
Excision of recurrent squamous cell carcinoma in parotid with Level LN clearance and Tonsillectomy | Mild | No | Not related | |
003 | Urinary tract infection | Mild | No | Not related |
Anaemia | Moderate | No | Not related | |
Worsening bowel cancer | Moderate | No | Not related | |
Moderately differentiated caecal adenocarcinoma requiring right hemicolectomy | Moderate | No | Not related | |
004 | Right Cellulitis post-Right THA | Mild | Yes | Not related |
006 | Severe left osteoarthritic hip with early changes of osteonecrosis | Mild | No | Not related |
008 | Left THA − elective | Moderate | No | Not related |
Cardiac arrest. | Severe | No | Not related | |
010 | THA | Mild | No | Not related |
Right benign obturator lesion | Mild | No | Not related | |
012 | NSTEMI Myocardial Infarction | Severe | No | Not related |
013 | Left hip pain post- THA | Mild | No | Not related |
Left hip greater trochanteric bursitis | Mild | No | Not related | |
Left THA | Mild | No | Not related | |
Left Hip Acetabular Revision (not the study Hip) | Mild | No | Not related | |
015 | Osteoarthritis left hip | No | ||
017 | Mallory Weiss Tear | Mild | No | Not related |
Benign prostatic Hypertrophy | Mild | No | Not related | |
Febrile Illness | Mild | No | Not related | |
019 | Osteoarthritis left hip THA | Mild | No | Not related |
Diffuse large B cell lymphoma and follicular lymphoma | Mild | No | Not related | |
Palpitations for Investigation | Mild | No | Not related | |
020 | Possible cardiac small vessel ischaemia secondary to T2DM | Mild | No | Not related |
Elective angiogram with PCI | Mild | No | Not related | |
021 | Admission to hospital with AF and delirium following slow cognitive decline | Severe | No | Not related |
TKA: Total Knee Arthroplasty; THA: Total Knee Arthroplasty.