FDA Adverse Event
Malfunction
Summary report: N
TRIDENT ALUMINA INSERT
MDR report key: 2318855
·
Received August 31, 2011
Report
- Report Number
- 9616680-2011-00575
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MRA
- PMA / PMN Number
- P000013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 "THE PT RECEIVED A "STRYKER SECUR-FIT" ARTIFICIAL HIP. IT WAS FURTHER ALLEGED THAT, THE PT IS EXPERIENCING "CONSTANT EMBARRASSING NOISE IN HIS HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ALUMINA INSERT | IMPLANT | MRA | STRYKER ORTHOPAEDICS CORK | NA | 16721102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |