FDA Adverse Event
Injury
Summary report: N
AXIOM PRIMARY TIBIAL INSERT
MDR report key: 91901
·
Received April 14, 1997
Report
- Report Number
- 1043534-1997-00060
- Event Type
- Injury
- Date Received
- April 14, 1997
- Date of Event
- April 10, 1997
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION STATEMENT: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
ORIGINAL LEFT TOTAL KNEE REPLACEMENT WAS 12/12/1994. DEVELOPED LEFT KNEE PAIN AND SWELLING ABOUT 2/1997. ON 4/10/1997 UNDERWENT REPLACEMENT OF THE PATELLA AND FEMORAL COMPONENT. OPERATIVE FINDINGS WERE POLYETHYLENE FAILURE OF THE LEFT TOTAL KNEE ARTHROPLASTY, WITH COMPLETE BICOMPARTMENTAL FAILURE OF LEFT KNEE ARTHROPLASTY, COMPLETE POLYETHYLENE WEAR THROUGH OF THE POSTERIOR HALF OF THE MEDIAL AND LATERAL SIDES OF THE KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXIOM PRIMARY TIBIAL INSERT Implant | KNEE COMPONENT - DEVICE 1 | JWH | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | P91C2906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |