FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN RIGHT STRYKER TITANIUM/CERAMIC IMPLANT HIP
MDR report key: 2844961
·
Received October 24, 2012
Report
- Report Number
- 9616680-2012-00924
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- January 1, 2007
- Report Date
- October 4, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT IS EXPERIENCING SOME SQUEAKING IN HIS RIGHT HIP. PT IS ALSO REPORTING THAT THE SQUEAKING STARTED SIX MONTHS AFTER SURGERY. PT IS SCHEDULED FOR AN UPCOMING APPOINTMENT WITH HIS PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGHT STRYKER TITANIUM/CERAMIC IMPLANT HIP | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |