FDA Adverse Event
Injury
Summary report: N
OMNIFIT SERIES I ACET. INSERT 10 28MM ID
MDR report key: 1993494
·
Received February 8, 2011
Report
- Report Number
- 2249697-2011-00140
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 14, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K980352
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "OSTEOLYSIS OF OLD LINER, LINER AND HEAD EXCHANGE ONLY. HOSPITAL PROTOCOL: NO X-RAYS OR MEDICAL RECORDS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT SERIES I ACET. INSERT 10 28MM ID | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | 9001R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other| R |