FDA Adverse Event
Other
Summary report: N
TRIDENT HEMISPHERICAL SOLID BK 58MM
MDR report key: 1297044
·
Received January 23, 2009
Report
- Report Number
- 9616680-2009-00017
- Event Type
- Other
- Date Received
- January 23, 2009
- Date of Event
- January 6, 2009
- Report Date
- January 5, 2009
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO 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, "THE PATIENT CLAIMS FAILURE OF HIS RIGHT HIP PROSTHESIS." NO FURTHER INFO IS AVAILABLE AT THIS TIME, ALTHOUGH IT HAS BEEN REQUESTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL SOLID BK 58MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | UNK | 19451701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |