FDA Adverse Event
Injury
Summary report: N
ACETABULAR LINER
MDR report key: 175479
·
Received July 2, 1998
Report
- Report Number
- 1825034-1998-00056
- Event Type
- Injury
- Date Received
- July 2, 1998
- Date of Event
- July 17, 1996
- Report Date
- July 1, 1998
- Manufacturer
- BIOMET, INC.
- Product Code
- KWB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON 2/22/1990. REVISION OF THE ACETABULAR LINER WAS PERFORMED ON 7/17/1996. PHYSICIAN STATES, "THE PLASTIC LINER APPEARS TO HAVE ERODED AWAY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACETABULAR LINER Implant | PROSTHESIS, HIP, COMP. | KWB | BIOMET, INC. | NA | 479130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |