INTEGRAL SHORT GTR W/2 CABLES

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - THE EVENT OCCURRED IN CANADA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 00223200518 (60526810), 00223200518 (60526810). ASSOCIATED PRODUCT INFORMATION: 139254 (330030), 157446 (995000), US157852(345040), 11-103201(654070). THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY WITH INTERNAL FIXATION OF A GREATER TROCHANTER FRACTURE AND SUBSEQUENTLY REQUIRED STAGED REVISIONS APPROXIMATELY 7 MONTHS POST-IMPLANTATION DUE TO PAIN, IMPLANT FRACTURE, AND SUSPECTED INFECTION. DURING THE FIRST-STAGE REVISION, FRACTURED CABLES, DEEP TISSUE INFECTION, AND SLIM MATERIAL AROUND THE IMPLANTS WERE NOTED. ALL COMPONENTS, INCLUDING THE CAGE AND CABLES, WERE REMOVED AND EXCHANGED FOR CEMENT SPACERS. THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS FOR LOW HEMOGLOBIN AND WAS PLACED ON ANTIBIOTIC THERAPY. APPROXIMATELY 3 MONTHS LATER, A PLANNED SECOND-STAGE REVISION WAS ATTEMPTED; HOWEVER, DUE TO PERSISTENT INFECTION, A REPEAT FIRST-STAGE REVISION WAS PERFORMED. THE PRIOR FEMORAL CRACK HAD PROGRESSED TO A LARGER DEFECT WITH POCKETS OF POLYMORPHONUCLEAR LEUKOCYTES, AND THE CEMENT SPACERS WERE EXCHANGED. THE PATIENT CONTINUED ANTIBIOTIC THERAPY. APPROXIMATELY 1 WEEK LATER, PATHOLOGY REPORTED NO ORGANISMS, AND THE PATIENT WAS CONSIDERED FREE OF INFECTION. THE SECOND-STAGE REVISION WAS COMPLETED APPROXIMATELY SEVERAL DAYS THEREAFTER, AND THE PATIENT AGAIN REQUIRED BLOOD TRANSFUSIONS FOR LOW HEMOGLOBIN. SUBSEQUENTLY, THE PATIENT DIED; THE CAUSE OF DEATH WAS UNKNOWN, AND THE COMPONENTS REMAINING IMPLANTED AT THAT TIME WERE NOT SPECIFIED. THE PATIENT UNDERWENT MULTIPLE STAGED REVISIONS AND LATER EXPIRED; THE CAUSE OF DEATH WAS UNKNOWN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.