ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 5, TAPER 12/14

Additional Manufacturer Narrative

INVESTIGATION RESULTS WERE MADE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: DURING THE TREND ANALYSIS NO TREND WAS IDENTIFIED. REVIEW OF EVENT DESCRIPTION: REVISION SURGERY DUE TO A PATIENT FALL WHICH RESULTED IN A PERIPROSTHETIC FRACTURE, STEM AND HEAD WERE EXPLANTED. ARCOS STEM AND FEMUR PLATED WITH 12-HOLE PROXIMAL NCBPP PLATE IMPLANTED. PRIMARY SURGERY ON (B)(6) 2016. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. ROOT CAUSE ANALYSIS AND CONCLUSION: IT WAS REPORTED THAT THE PATIENT HAD A FALL WHICH RESULTED IN A BONE FRACTURE. THE ONLY AVAILABLE INFORMATION IS THAT THE STEM AND HEAD WERE REMOVED. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT WAS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY WERE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL WAS UNKNOWN. IT CAN BE HIGHLY ASSUMED THAT THE BONE FRACTURE WAS OCCURRED DUE TO THE PATIENT FALL. NO INFORMATION WAS PROVIDED ABOUT THE IMPLANTS. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4)..

Additional Manufacturer Narrative

THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AN E-MAIL REQUESTING THE FOLLOWING ADDITIONAL INFORMATION WAS SENT ON MARCH 17, 2017 TO THE APPROPRIATE REPRESENTATIVES. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED THE ALLOCLASSIC SL STEM, OFFSET, UNCEMENTED, 5, TAPER 12/14 ON UNKNOWN SIDE ON (B)(6) 2016. THE PATIENT WAS REVISED ON UNKNOWN DATE DUE TO PERIPROSTHETIC FRACTURE CAUSED BY PATIENT'S FALL. NOTE: AS NO EVENT DATE WAS PROVIDED, IT WAS LEFT BLANK.