OFFSET TIB TRAY 5.0MM ADAPTOR

Description of Event or Problem

IT WAS REPORTED A PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A BILATERAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE ON (B)(6) 2011 DUE TO PAIN, CELLULITIS AND INFECTION. OPERATIVE REPORT CONFIRMED ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2011. PATIENT FURTHER UNDERWENT A LEFT KNEE RADICAL DEBRIDEMENT PROCEDURE ON MARCH 25, 2011 DUE TO A HEMATOMA. PATIENT UNDERWENT A SECOND LEFT KNEE REVISION PROCEDURE ON (B)(6) 2011 DUE TO A RECURRENT NON-HEALING WOUND. OPERATIVE REPORT CONFIRMED ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS. PATIENT UNDERWENT A LEFT KNEE RE-RADICAL DEBRIDEMENT PROCEDURE ON (B)(6) 2011 DUE TO INFECTION. OPERATIVE REPORT CONFIRMED THE CEMENT SPACERS WERE REMOVED AND REPLACED. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2011.

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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 1 OF 10 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-05156 / 05165).