FDA Adverse Event
Injury
Summary report: N
TRIATHLON #5 CR INSERT 9MM
MDR report key: 2090873
·
Received May 12, 2011
Report
- Report Number
- 9610726-2011-00158
- Event Type
- Injury
- Date Received
- May 12, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 26, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K040267
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 INFORMATION 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, "REVISION SURGEON'S ASSESSMENT; FAILED RIGHT KNEE REPLACEMENT SECONDARY TO PATELLOFEMORAL ABNORMALITIES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON #5 CR INSERT 9MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | LBP345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |