UNKNOWN CABLE

Additional Manufacturer Narrative

(B)(4). D10: UNK CABLE CAT#NI LOT#NI. UNK GTR PLATE CAT#NI LOT#NI. G2: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 4 MONTHS AGO DUE TO A HIP DISLOCATION. DURING THE PROCEDURE, IT WAS NOTED THAT 2 RETAINED CERCLAGE CABLES FROM A PREVIOUS REVISION (IMPLANTED APPROXIMATELY 9.5 YEARS AGO) HAD FRACTURED. SIGNIFICANT EDEMA, SCAR TISSUE, AND METALLOSIS WERE ALSO FOUND. THE 2 FRACTURED PLATES WERE EXPLANTED ALONG WITH THE TROCHANTERIC PLATE AND THE HIP PROCEDURE WAS COMPLETED WITHOUT ANY ADDITIONAL COMPLICATIONS. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Description of Event or Problem

NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ¿PATIENT DISLOCATED¿ ¿ REVISION ; FALL AT HOME 3 DAYS PRIOR, VAGUE HISTORY, HAS BEEN MOBILIZING AROUND IN A CHAIR WITH WHEELS SINCE; REVISION OP NOTE : LEFT HIP REVISION DUE TO PERIPROSTHETIC DISLOCATION , POSTERIOR APPROACH USING PREVIOUS INCISION, CONSIDERABLE EDEMA ENCOUNTERED WITHIN SUBQ TISSUE, SEROUS APPEARING FLUID, NO FRANK PUS , SIGNIFICANT SCAR TISSUE WITH METALLOSIS ENCOUNTERED , BROKEN CABLES REMOVED, FEMORAL HEAD FOUND TO BE SUPERIOR TO ACETABULAR COMPONENT, NO SIGNIFICANT GT, GT PLATE REMOVED AND SENT FOR CULTURE, NOTES CUT OFF, NO ADDITIONAL INFORMATION PROVIDED. IT WAS INDICATED THAT THE PATIENT FELL AND EXPERIENCED A DISLOCATION, AND AN OFF LABEL COMBINATION WAS USED IN THE HIP ARTHROPLASTY COVERED UNDER A SEPARATE COMPLAINT. HOWEVER, WITH THE INFORMATION PROVIDED, IT IS UNKNOWN IF THESE FACTORS CONTRIBUTED TO THE REVISION OF THE PLATE AND CABLE BREAKAGE. AS SUCH, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT WAS CONFIRMED THROUGH MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.