FDA Adverse Event
Injury
Summary report: N
TRIDENT CERAMIC ACETABULAR SYSTEM
MDR report key: 2062546
·
Received April 7, 2011
Report
- Report Number
- 9616680-2011-00178
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- June 6, 2006
- Report Date
- March 18, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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: "IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PT REC'D A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PT IS EXPERIENCING "VIBRATION IN HIS HIP WHILE, POPPING AND SQUEAKING, AND PAIN IN THE HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT CERAMIC ACETABULAR SYSTEM | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |