FDA Adverse Event
Injury
Summary report: N
UNKNOWN OMNIFLEX STEM
MDR report key: 2471019
·
Received February 24, 2012
Report
- Report Number
- 2249697-2012-00234
- Event Type
- Injury
- Date Received
- February 24, 2012
- Date of Event
- February 2, 2012
- Report Date
- February 2, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDK
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT COMPLAINED OF HIP PAIN. STEM WAS LOOSE, CUP WAS LOOSE DR REVISED CUP AND STEM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN OMNIFLEX STEM | IMPLANT | JDK | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |