FDA Adverse Event
Other
Summary report: N
DURACON CS TIBIA INSERT SM 16
MDR report key: 1635186
·
Received March 15, 2010
Report
- Report Number
- 9610726-2010-00090
- Event Type
- Other
- Date Received
- March 15, 2010
- Date of Event
- March 1, 2010
- Report Date
- March 1, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K021451
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT COMPLAINED OF PAIN. DURING PRIMARY SURGERY IN 2001 THE PATELLA WAS NEVER RESURFACED. DURING REVISION SURGERY ON (B)(6) 2010, THE DOCTOR RESURFACED THE PATELLA. AS LONG AS HE HAD THE KNEE EXPOSED, HE REPLACED THE TIBIAL INSERT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACON CS TIBIA INSERT SM 16 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | TBK847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |