Subject | Study Group | Number of SAEs | Description |
---|---|---|---|
2F | Xenograft | 1 | • Surgical site stitch abscess |
2Oa | Xenograft | 1 | • Device infection requiring graft removal |
2AE | Xenograft | 1 | • Persistent effusion and pain |
4Da | Xenograft | 2 | • Post-op septic arthritis • Persistent effusion requiring graft removal |
4Fa | Xenograft | 1 | • Synovitis, tibial tunnel osteomyelitis requiring graft removal |
7Aa | Xenograft | 4 | • Persistent inflammation and surgical site fistula • Tibial screw removal • Tibial tunnel osteomyelitis • Persistent inflammation, surgical site fistula requiring graft removal |
7D | Xenograft | 1 | • Persistent pain |
7E | Xenograft | 1 | • Traumatic ACL re-rupture |
7I | Allograft | 1 | • Myocardial infarction |
7 Na | Xenograft | 3 | • Synovitis • Persistent inflammation, surgical site fistula requiring graft removal • Surgical site septic arthritis, post graft removal |
8Ba | Xenograft | 1 | • Traumatic ACL re-rupture |