BIOMET ILOK PRI TIB TRAY 71MM
Received Mar 19, 2015 · Event occurred Feb 25, 2015
Report 0001825034-2015-01064 · MDR key 4618734
Device
Generic name
Prosthesis, Knee
Manufacturer
Biomet OrthopedicsModel number
N/ACatalog number
141213
Lot number
008810
Product problems
- Metal Shedding Debris
- Naturally Worn
Patient
Not reported
- Toxicity
- Reaction
- Test Result
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON (B)(6) 2003. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2015 DUE TO POLY WEAR LEADING TO METALLOSIS. ALL COMPONENTS WERE REMOVED AND REPLACED.
Additional Manufacturer Narrative
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. (B)(4). THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS; ¿MATERIAL SENSITIVITY REACTIONS, PARTICULATE WEAR DEBRIS AND DISCOLORATION FROM METALLIC AND POLYETHYLENE COMPONENTS OF JOINT IMPLANTS MAY BE PRESENT IN ADJACENT TISSUE OR FLUID¿ AND "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015- 01062 / 01064).