FDA Adverse Event
Injury
Summary report: N
SLR BIPOLAR ACETABULAR SHELL
MDR report key: 1021987
·
Received March 28, 2008
Report
- Report Number
- 1043534-2008-00051
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- February 13, 2008
- Report Date
- March 6, 2008
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- JDI
- PMA / PMN Number
- K840357
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN REC'D FROM THE USER FACILITY. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2008-00052.
Description of Event or Problem · 1
ALLEGEDLY BIPOLAR ACETABULAR LINER COMPONENT BROKE IN-SITU. PT WAS HAVING PAIN IN HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLR BIPOLAR ACETABULAR SHELL | JDI | WRIGHT MEDICAL TECHNOLOGY, INC. | 010A115128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |