FDA Adverse Event
Malfunction
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER 60MM
MDR report key: 1587562
·
Received January 12, 2010
Report
- Report Number
- 9616680-2010-00026
- Event Type
- Malfunction
- Date Received
- January 12, 2010
- Date of Event
- December 28, 2009
- Report Date
- December 29, 2009
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. 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 THAT, "THE PATIENT CLAIMS FAILURE OF HER HIP PROTHESIS." NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME, ALTHOUGH IT HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER 60MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 7499201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |