FDA Adverse Event
Injury
Summary report: N
AGC V2 INTERLOK TIBIAL
MDR report key: 1033079
·
Received April 22, 2008
Report
- Report Number
- 3002806535-2008-00008
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 1, 2008
- Report Date
- March 27, 2008
- Manufacturer
- BIOMET UK LTD.
- Product Code
- JWH
- PMA / PMN Number
- K921182
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. H3: EVALUATION IS IN PROGRESS BUT NOT YET COMPLETE. THIS REPORT FILED APRIL 22, 2008.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 1999. REVISION PROCEDURE WAS PERFORMED IN 2008, WEAR/DAMAGE WAS IDENTIFIED ON THE POLYETHYLENE SURFACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AGC V2 INTERLOK TIBIAL | JWH | BIOMET UK LTD. | NA | 249602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R |