FDA Adverse Event
Injury
Summary report: N
OMNIFIT SERIES I ACET. INSERT 10 26MM ID
MDR report key: 2573971
·
Received May 8, 2012
Report
- Report Number
- 2249697-2012-00581
- Event Type
- Injury
- Date Received
- May 8, 2012
- Date of Event
- April 23, 2012
- Report Date
- April 23, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K900438
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LFIT MORSE TAPER HEAD, CAT # 01-2605, LOT # UNK WAS ALSO LISTED IN THIS REPORT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED ECCENTRIC HEAD LOCATION WITH POLY WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT SERIES I ACET. INSERT 10 26MM ID | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |