FDA Adverse Event
Injury
Summary report: N
UNKNOWN TRIDENT CERAMIC ACETABULAR SYSTEM
MDR report key: 2202472
·
Received August 5, 2011
Report
- Report Number
- 9616680-2011-00530
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 28, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFO 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 ALLEGEDLY, "THE PT RECEIVED A TRIDENT ACETABULAR SYSTEM." IT WAS FURTHER ALLEGED THAT THE PT IS EXPERIENCING, 'LOOSENING' AND DISCOMFORT FROM THE SYSTEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN TRIDENT CERAMIC ACETABULAR SYSTEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |