BIOMET POR PRI TIB TRAY 67MM

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. 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 A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE APPROXIMATELY 11 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO LAXITY AND OSTEOLYSIS. DURING THE REVISION PROCEDURE, THE SURGEON NOTED THE BEARING HAD WORN THROUGH, CAUSING THE LOCKING BAR TO FRACTURE. A PIECE OF THE LOCKING BAR REMAINS IN THE PATIENT. THE FEMORAL COMPONENT, BEARING, AND TIBIAL COMPONENT WERE REMOVED AND REPLACED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE CONFIRMED THE REPORTED CONDITION. A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, ¿FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT.¿

Description of Event or Problem

DURING A KNEE REVISION PROCEDURE OCCURRING APPROXIMATELY 16 YEARS POST-IMPLANTATION DUE TO LAXITY AND OSTEOLYSIS, IT WAS NOTED THAT THE TIBIAL BEARING HAD WORN THROUGH, CAUSING THE LOCKING BAR TO FRACTURE. A PIECE OF THE LOCKING BAR WAS RETAINED BY THE PATIENT.

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. DATE IMPLANTED - APPROXIMATELY 11 YEARS AGO. THIS REPORT IS NUMBER 1 OF 2 MDR'S FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-00588 / 01650).

Description of Event or Problem

DURING A KNEE REVISION PROCEDURE APPROXIMATELY 11 POST-IMPLANTATION DUE TO LAXITY AND OSTEOLYSIS, IT WAS NOTED THAT THE TIBIAL BEARING HAD WORN THROUGH, CAUSING THE LOCKING BAR TO FRACTURE. A PIECE OF THE LOCKING BAR WAS RETAINED BY THE PATIENT.