Event group | Definition and specification |
---|---|
Device events | Events affecting any component of the implanted device or material, or the instrumentation used for their implantation. |
• Instrument problem (breakage, failure) • Implant (breakage, malpositioning, separation, separation, screw/bolt joint surface perforation requiring immediate postoperative surgical revision) • Cementation problems (augmentation) | |
Osteochondral events | Events affecting the osteochondral tissue of the proximal humerus, clavicula and/or scapula |
Articular cartilage damage • iatrogenic Fracture (including hairline fracture): humerus metaphyseal (proximal to “surgical neck”); humerus diaphyseal; scapula | |
Soft tissue events | Events involving only the soft tissue at the treated shoulder |
• Skin, muscle, tendon, joint capsule, ligament, labrum • Blood vessels (bleeding): bleeding at the surgical site that requires additional intervention or leads to a stop of the operation • Nervesb: recognized damage of a neurological structure |