FDA Adverse Event
Injury
Summary report: N
BIOMET M2A MAGNUM HIP IMPLANT
MDR report key: 3193415
·
Received June 21, 2013
Report
- Report Number
- MW5030658
- Event Type
- Injury
- Date Received
- June 21, 2013
- Date of Event
- September 18, 2012
- Report Date
- June 14, 2013
- Manufacturer
- BIOMET, INC ET AL
- Product Code
- JDO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
BIOMET M2A MAGNUM HIP IMPLANT DISLOCATED HIP TWICE. NEEDED HIP REVISION CHROMIUM AND COBALT IN BLOOD ABNORMALLY HIGH. PUSS POCKET AND FLUID POCKETS PRESENT WHEN REVISION TOOK PLACE. PAIN IN HIP ANKLE AND KNEE PRIOR TO REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283200 | BIOMET M2A MAGNUM HIP IMPLANT | METAL ON METAL | JDO | BIOMET, INC ET AL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R |