FDA Adverse Event
Injury
Summary report: N
OMNIFIT SER. II INSERT-10 DEG.
MDR report key: 2705615
·
Received August 13, 2012
Report
- Report Number
- 9616680-2012-00645
- Event Type
- Injury
- Date Received
- August 13, 2012
- Date of Event
- July 20, 2012
- Report Date
- July 20, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LPH
- PMA / PMN Number
- K943054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 06-2800, LOT # 32776001, DESCRIPTION: C-TAPER COCR LFIT HEAD 28MM/0. CAT # 2051-2062, LOT # 31876101, DESCRIPTION: SECUR-FIT HA PSL CUP/CLUSTER SHELL 62MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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 DOCTOR THOUGHT THE HIP WAS INFECTED. DOCTOR WASHED OUT THE HIP AND PUT IN A NEW CUP LINER AND HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT SER. II INSERT-10 DEG. | IMPLANT | LPH | STRYKER ORTHOPAEDICS CORK | NA | 31360501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 96 YR | Other| R |