FDA Adverse Event
Malfunction
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 50MM
MDR report key: 1962905
·
Received December 22, 2010
Report
- Report Number
- 9616680-2010-00860
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 14, 2010
- Report Date
- December 14, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT THE PT UNDERWENT A TOTAL RIGHT HIP REPLACEMENT SURGERY ON (B)(6), 2006. IT WAS FURTHER ALLEGED THAT, "THE PT IS EXPERIENCING PROBLEMS FROM THE SYSTEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 50MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 18923101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |