FDA Adverse Event
Injury
Summary report: N
TRIDENT ACETABULAR SYSTEM
MDR report key: 2072478
·
Received April 7, 2011
Report
- Report Number
- 9616680-2011-00182
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- October 2, 2007
- 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
- PA, 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 THAT: "IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT ACETABULAR HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT IS EXPERIENCING "LOOSENING" FROM THE 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 | Required Intervention |