FDA Adverse Event
Injury
Summary report: N
LCS ROT PLAT BEARINGS GP
MDR report key: 691523
·
Received March 23, 2006
Report
- Report Number
- 1818910-2006-00773
- Event Type
- Injury
- Date Received
- March 23, 2006
- Date of Event
- February 26, 2006
- Report Date
- February 26, 2006
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HRY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PATIENT WAS REVISED DUE TO SUBSIDENCE OF HTE TIBIAL TRAY. MINIMAL POLY WEAR WAS EVIDENT ON THE INSERT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LCS ROT PLAT BEARINGS GP | TOTAL KNEE REPLACEMENT | HRY | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |