FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN CERAMIC ON CERAMIC HIP
MDR report key: 1033030
·
Received April 22, 2008
Report
- Report Number
- 9616680-2008-00095
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- March 25, 2007
- Report Date
- March 25, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- NI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, NEITHER THE DEVICE NOR ADD'L INFO IS AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT IS EXPERIENCING SQUEAKING AND PAIN DEEP IN HIP AREA. PT IS NOW WALKING WITH CANE, DUE TO PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN CERAMIC ON CERAMIC HIP | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |