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Table 2 Serious Adverse Event Data Summary

From: Xenograft for anterior cruciate ligament reconstruction was associated with high graft processing infection

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

  1. NOTE: a indicates subject received device associated with water-based pathogen