22.2MM DIA COCR MOD HEAD -5 NK

Description of Event or Problem

LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE AND UNDERWENT A REVISION PROCEDURE ON AN UNKNOWN DATE DUE TO PATIENT ALLEGATIONS OF PAIN, LACK OF MOBILITY, METALLOSIS, INFLAMMATION AND DAMAGE TO SURROUNDING BONE AND TISSUE. A REVIEW OF INVOICE HISTORY INDICATES PROCEDURES ON (B)(6) 2000, (B)(6) 2002, (B)(6) 2004 AND (B)(6) 2009. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

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 6 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 11 STATES, ¿INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS.¿ NUMBER 19 STATES, ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-04996 / 04998).