FDA Adverse Event
Malfunction
Summary report: N
MICROPLASTY ACETABULAR IMPACTOR HANDLE
MDR report key: 1212639
·
Received October 29, 2008
Report
- Report Number
- 1825034-2008-00286
- Event Type
- Malfunction
- Date Received
- October 29, 2008
- Report Date
- October 3, 2008
- Manufacturer
- BIOMET INC.
- Product Code
- HWA
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. THIS REPORT FILED OCTOBER 29, 2008.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE 2008. DURING PROCEDURE, INSTRUMENT BROKE WHILE INSERTING ACETABULAR CUP. TWO (2) PIECES WERE RETRIEVED FROM THE WOUND SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROPLASTY ACETABULAR IMPACTOR HANDLE | INSTRUMENT, MANUAL | HWA | BIOMET INC. | N/A | 602360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR |