FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT STRYKER TITANIUM/CERAMIC IMPLANT HIP
MDR report key: 2821515
·
Received October 24, 2012
Report
- Report Number
- 9616680-2012-00926
- Event Type
- Injury
- Date Received
- October 24, 2012
- Date of Event
- February 1, 2010
- Report Date
- October 4, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWB
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SOME SORENESS IN HIS LEFT HIP. PATIENT IS ALSO REPORTING THAT THE SORENESS STARTED SIX MONTHS AGO. PATIENT IS SCHEDULED FOR AN UPCOMING APPOINTMENT WITH HIS PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT STRYKER TITANIUM/CERAMIC IMPLANT HIP | IMPLANT | KWB | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |