FDA Adverse Event
Injury
Summary report: N
ORTHOLOC ADVANTIM TOT COND TIBIAL INSERT
MDR report key: 45124
·
Received October 25, 1996
Report
- Report Number
- 1043534-1996-00031
- Event Type
- Injury
- Date Received
- October 25, 1996
- Date of Event
- September 13, 1996
- Report Date
- October 24, 1996
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION STATEMENT: RECORDS REVIEWED OF PRODUCT LOT FILE AND FOUND TO BE COMPLETE, ACCURATE, AND ACCEPTABLE. PRODUCT WAS MANUFACTURED AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.
Description of Event or Problem · 1
PT HAD A LEFT TOTAL KNEE REPLACEMENT ON 2/22/91 AND DEVELOPED A FAIRLY SUDDEN VALGUS ANGULATION OF THE KNEE AND A SCRAPING TYPE FEELING. IT WAS DETERMINED THAT ALLEGEDLY THE TIBIAL POLY COMPONENT FAILED AND THE DEVICE WAS EXPLANTED ON 9/13/96. IT'S FAILURE TO MEET EXPECTATIONS RESULTS IN A SECOND SURGICAL PROCEDURE AND PROLONGED HOSPITALIZATION FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOLOC ADVANTIM TOT COND TIBIAL INSERT Implant | KNEE COMPONENT - DEVICE 1 | JWH | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 030M418260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |