FDA Adverse Event
Summary report: N
MALLORY ACETABULAR LINER SIZE C STANDARD 32 MM ID
MDR report key: 14058
·
Received June 16, 1994
Report
- Report Number
- MW1002494
- Date Received
- June 16, 1994
- Manufacturer
- BIOMET, INC.
- Product Code
- KWB
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO RPTR, THE DR WANTS THE PROSTHESIS ANALYZED AND THE PT WANTS THE COMPONENT HIMSELF. THE DR SAID THIS WAS THE WORST CASE OF OSTEOLYSIS HE HAD EVER SEEN. TITANIUM WAS FOUND IN THE SOFT TISSUE AND BONE. (SAME PT REFERRED TO IN 1002493.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLORY ACETABULAR LINER SIZE C STANDARD 32 MM ID | KWB | BIOMET, INC. | 523690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |