FDA Adverse Event
Malfunction
Summary report: N
BIOMET CC CRUCIATE TRAY
MDR report key: 1052096
·
Received May 20, 2008
Report
- Report Number
- 1825034-2008-00149
- Event Type
- Malfunction
- Date Received
- May 20, 2008
- Date of Event
- December 11, 2007
- Report Date
- December 12, 2007
- Manufacturer
- BIOMET, INC.
- Product Code
- JWH
- PMA / PMN Number
- K915132
- Removal / Correction Number
- Z-706/707-08
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF RETURNED DEVICE FOUND LOTS WERE SWITCHED AND INCORRECTLY LABELED AT THE BOX AND LABEL STEP OF PRODUCTION. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B) (6) 2007, PACKAGE LABELED 141234, LOT 448740, 75MM WAS OPENED. WHEN IMPLANT WAS INTRODUCED TO STERILE FIELD, IT WAS FOUND TO BE MARKED 141232, LOT 448530, 67MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOMET CC CRUCIATE TRAY | JWH | BIOMET, INC. | NA | 448740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |