Table 2.
Serious Adverse Event Data Summary
| 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 |
NOTE: a indicates subject received device associated with water-based pathogen