FDA Adverse Event
Malfunction
Summary report: N
ADVANTIM UNICONDYLAR TIBIAL INSERT
MDR report key: 139614
·
Received December 15, 1997
Report
- Report Number
- 1043534-1997-00210
- Event Type
- Malfunction
- Date Received
- December 15, 1997
- Report Date
- November 14, 1997
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HSH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: PRODUCT WAS NOT RETURNED FOR INVESTIGATION. PRODUCT WAS MFG AND SOLD BY DOW CORNING WRIGHT, THE ASSETS OF WHICH WERE PURCHASED BY WRIGHT MEDICAL TECHNOLOGY, INC.
Description of Event or Problem · 1
ALLEGEDLY INSERT HAS DELAMINATION. REVISION SURGERY HAS BEEN SCHEDULED FOR 1/21/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTIM UNICONDYLAR TIBIAL INSERT Implant | KNEE COMPONENT | HSH | WRIGHT MEDICAL TECHNOLOGY, INC. | NA | 100M513920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |