BIOMET ILOK PRI TIB TRAY 75MM

Additional Manufacturer Narrative

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH AS THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND FURTHER MEDWATCH REPORTS WILL BE SUBMITTED, IF NECESSARY.

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT KNEE ARTHOPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO METALLOSIS.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION AND ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-04893-1 / 2016-00003 / 2016-00004).

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT INITIAL LEFT KNEE ARTHOPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6), 2015 DUE TO METALLOSIS.ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REVISION PROCEDURE ON (B)(6), 2015, ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCT.