FDA Adverse Event
Injury
Summary report: N
UHR BIPOLAR 26X48MM
MDR report key: 3844681
·
Received June 3, 2014
Report
- Report Number
- 0002249697-2014-02030
- Event Type
- Injury
- Date Received
- June 3, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 12, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- KWL
- PMA / PMN Number
- K800207
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
DISLOCATED HIP COMPONENTS AS SEEN ON X-RAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 324640 | UHR BIPOLAR 26X48MM | IMPLANT | KWL | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |