FDA Adverse Event
Malfunction
Summary report: N
UNK CERAMIC ON CERAMIC HIP
MDR report key: 1122206
·
Received May 1, 2008
Report
- Report Number
- 9616680-2008-00108
- Event Type
- Malfunction
- Date Received
- May 1, 2008
- Date of Event
- June 15, 2003
- Report Date
- March 26, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MRA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVAL. ADDITIONAL INFO HAS BEEN REQUESTED.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT TO FDA'S WEBSITE: "I HAD MY LEFT HIP REPLACED IN '03. ABOUT A YR LATER, I NOTICED IT SQUEAKING, AND ASKED MY SURGEON ABOUT THIS, AND HE SAID THE REPLACEMENT WAS PERFECT. I THEN HAD MY RIGHT HIP REPLACED IN 04. I NOW HAVE BOTH HIPS SQUEAKING THAT COMES AND GOES. I AM CONCERNED ABOUT THE LONGEVITY OF MY HIP REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK CERAMIC ON CERAMIC HIP | IMPLANT | MRA | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |