FDA Adverse Event
Injury
Summary report: N
OMNIFIT SER. II INSERT 20 DEG.
MDR report key: 1071400
·
Received July 3, 2008
Report
- Report Number
- 9616680-2008-00180
- Event Type
- Injury
- Date Received
- July 3, 2008
- Date of Event
- December 6, 2007
- Report Date
- June 12, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K903636
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT HAD A TOTAL HIP REPLACEMENT IN 2001. IN 2007, THE PT HAD TO UNDERGO ANOTHER HIP REPLACEMENT ON THE SAME LEFT HIP AS THE PLASTIC COATING ON THE ACETABULAR COMPONENT HAD WORN AWAY AND METAL WAS RUBBING AGAINST METAL CAUSING DAMAGE TO HIP BONES, NECESSITATING TWO BONE GRAFTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT SER. II INSERT 20 DEG. | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | GV271055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |