FDA Adverse Event
Malfunction
Summary report: N
BIOMET
MDR report key: 602293
·
Received May 9, 2005
Report
- Report Number
- MW1035421
- Event Type
- Malfunction
- Date Received
- May 9, 2005
- Date of Event
- April 18, 2005
- Report Date
- May 9, 2005
- Manufacturer
- BIOMET
- Product Code
- KWB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT CAME TO SEE SURGEON AFTER EXPERIENCING A "POP" IN HIP. A REVISION OF TOTAL HIP PROCEDURE PERFORMED IN 1996 WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET | RINGLOC ACETABULAR LINER 28MM 10 DEGREE SIZE 22 | KWB | BIOMET | * | 026750 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |