FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT-RIGHT TRIATHLON KNEE
MDR report key: 1871260
·
Received October 13, 2010
Report
- Report Number
- 9610726-2010-00357
- Event Type
- Injury
- Date Received
- October 13, 2010
- Date of Event
- June 22, 2010
- Report Date
- September 27, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT 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 ON (B)(6), 2010, PATIENT HAD A DIFFERENT SURGEON, SURGEON PERFORMED A REVISION SURGERY. THREE MONTHS LATER, HE IS STILL IN THERAPY, BUT IS STILL FEELING PAIN. PATIENT STATED THAT FIRST SURGEON HAD NICKED A NERVE AND HE NOW HAS NERVE DAMAGE IN THAT KNEE. PATIENT STATED THAT, THE REVISION SURGEON, STATED THAT THE KNEE WAS "SHOT" AND NEEDED TO BE REPLACED. PATIENT BELIEVES THAT THERE WAS A PROBLEM WITH THE IMPLANT ITSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT-RIGHT TRIATHLON KNEE | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |