FDA Adverse Event
Injury
Summary report: N
UNKNOWN DURACON RIGHT KNEE IMPLANT
MDR report key: 2150601
·
Received June 23, 2011
Report
- Report Number
- 9616680-2011-00420
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- April 15, 2011
- Report Date
- June 3, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "(B)(6), 2011, X-RAY SHOWED THAT A SCREW IS LOOSE IN RIGHT KNEE IMPLANT. REVISION SURGERY SCHEDULED FOR (B)(6)-2011."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DURACON RIGHT KNEE IMPLANT | IMPLANT | JWH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |