FDA Adverse Event
Injury
Summary report: N
BIOMET
MDR report key: 1131167
·
Received August 20, 2008
Report
- Report Number
- 1131167
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- August 8, 2008
- Report Date
- August 18, 2008
- Manufacturer
- BIOMET
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT HAD BIPOLAR HIP PROCEDURE IN 2008. ABOUT 2 DAYS LATER, THE PT WAS TAKEN TO THE OR FOR RECURRENT HIP DISLOCATION. DURING SURGERY, IT WAS DISCOVERED THAT FEMORAL HEAD WAS DISLOCATED FROM THE BIPOLAR HEAD (DISSOCIATION OF HIP AND STEM).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | HIP PROSTHESIS | JDI | BIOMET | 808470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |