FDA Adverse Event
Malfunction
Summary report: N
CERAMIC ON CERAMIC HIP
MDR report key: 1872176
·
Received October 13, 2010
Report
- Report Number
- 9616680-2010-00634
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 23, 2010
- Report Date
- September 23, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 BY THE PT THAT, "ALLEGEDLY THE PT UNDERWENT A CERAMIC HIP REPLACEMENT SURGERY ABOUT 6-8 YEARS AGO AND AFTER A FEW YEARS HIS HIP BEGAN TO SQUEAKING."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CERAMIC ON CERAMIC HIP | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |