FDA Adverse Event
Malfunction
Summary report: N
TRIDENT ACETABULAR SYSTEM
MDR report key: 1916322
·
Received November 29, 2010
Report
- Report Number
- 9616680-2010-00774
- Event Type
- Malfunction
- Date Received
- November 29, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 12, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADD'L 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 THAT, "THE PT UNDERWENT A TRIDENT HIP REPLACEMENT SURGERY." IT WAS FURTHER REPORTED THAT, "THE PT ALLEGES DAMAGES FOR AN UNK INJURY RELATING TO THE TRIDENT SYSTEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ACETABULAR SYSTEM | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |