22.2MM DIA COCR MOD HD STD NK

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 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2016-02715 / 02716). ADDITIONAL EVENTS FOR THIS PATIENT REPORTED ON MEDWATCH NUMBERS 1825034-2016-02713 / 02714 AND 02717 / 02719. NOT RETURNED BY ATTORNEY.

Description of Event or Problem

LEGAL COUNSEL REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO ALLEGED DISLOCATION. THE FEMORAL HEAD AND ACETABULAR LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFFCOMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.