FDA Adverse Event
Injury
Summary report: N
UNKNOWN STEM
MDR report key: 2181596
·
Received July 27, 2011
Report
- Report Number
- 1825034-2011-00649
- Event Type
- Injury
- Date Received
- July 27, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 1, 2011
- Manufacturer
- BIOMET UK LTD
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. IMPLANTED DATE - 2000; EXACT DATE UNKNOWN. MANUFACTURE DATE - UNKNOWN. (B)(4).
Additional Manufacturer Narrative · 1
INFORMATION RECEIVED INDICATES THE COMPONENT WAS NOT MANUFACTURED BY BIOMET ORTHOPEDICS.THIS REPORT FILED (B)(4), 2011.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2000. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2011 DUE TO FRACTURE OF THE LOCKING SCREW BETWEEN THE FEMORAL STEM AND FEMORAL COMPONENT. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN STEM | PROSTHESIS, KNEE | JWH | BIOMET UK LTD | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |