FDA Adverse Event
Injury
Summary report: N
TRIATHLON-PRIM TIB BASEPLATE USAE MOLD #1434
MDR report key: 2032693
·
Received March 17, 2011
Report
- Report Number
- 9610726-2011-00078
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- March 2, 2011
- Report Date
- March 2, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K031729
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "UPON EXAMINATION, TIBIAL TRAY HAD LOOSENED FROM THE CEMENT MANTEL NECESSITATING A REVISION OF A CR KNEE TO A PS KNEE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-PRIM TIB BASEPLATE USAE MOLD #1434 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SKPLA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |