FDA Adverse Event
Injury
Summary report: N
SIG MOD TIB TRAY CEM COCR 2
MDR report key: 1861995
·
Received October 7, 2010
Report
- Report Number
- 1818910-2010-06376
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 24, 2010
- Manufacturer
- DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- JWH
- PMA / PMN Number
- K032151
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PT WAS REVISED TO ADDRESS TIBIAL LOOSENING AND SUBSIDENCE. SURGEON SUSPECTS THAT TRUMATCH BLOCKS CAUSED THE TIBIA TO BE CUT INTO VARUS, CAUSING THE LOOSENING AND SUBSIDENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIG MOD TIB TRAY CEM COCR 2 | 87JWH | JWH | DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 2496799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |