FDA Adverse Event
Malfunction
Summary report: N
BIOMET METAL-ON-METAL PROSTHETIC HIP JOINT
MDR report key: 2232291
·
Received August 26, 2011
Report
- Report Number
- MW5021939
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Report Date
- August 26, 2011
- Manufacturer
- BIOMET
- Product Code
- KWA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PATIENT HAD A BIOMET METAL-ON-METAL HIP JOINT IMPLANTED ON (B)(6) 2009. THE BIOMET METAL-ON-METAL HIP JOINT RESULTED IN THE FOLLOWING ADVERSE HEALTH CONSEQUENCES AMONG OTHERS: EXTREME PAIN AND IMMOBILITY OF THE PROSTHETIC HIP; GROWTH OF PSEUDOTUMORS AROUND AND NEAR THE PROSTHETIC HIP; TISSUE DEGENERATION NEAR AND AROUND THE PROSTHETIC HIP; HIGHLY NEGATIVE BLOOD MARKERS SHOWING INTENSE INFLAMMATION AND OTHER REACTIONS AT THE PROSTHETIC HIP; INTENSE FATIGUE AND MALAISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET METAL-ON-METAL PROSTHETIC HIP JOINT | ARTIFICIAL HIP | KWA | BIOMET |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |