CEMENTRALIZER 15.0

Additional Manufacturer Narrative

EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED ONE OTHER REPORT AGAINST THE FEMORAL HEAD AND NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/PRODUCT LOT CODE COMBINATIONS. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Additional Manufacturer Narrative

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

Description of Event or Problem

NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION PAPERS ALLEGE THE PATIENT WAS REVISED DUE TO IMPLANT FAILURE. UPDATE REC'D 4/21/2015- AMENDED LITIGATION PAPERS RECEIVED. ORIGINAL LITIGATION INDICATED THAT THE PATIENT WAS IMPLANTED WITH ASR; HOWEVER, AMENDED LITIGATION ALLEGES THAT THE PATIENT WAS IMPLANTED WITH PINNACLE. THE PRODUCTS HAVE BEEN UPDATED AND FOLLOW-UPS CREATED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DAMAGE TO HER HIP JOINTS AND BODY. LITIGATION IDENTIFIED THAT THIS COMPLAINT IS FOR THE RIGHT HIP. UPDATE 10/9/2015 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT HAD A POLY/METAL CONSTRUCT, NOT METAL/METAL. ALL IMPLANTS ARE NOW BEING REPORTED, AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF PAIN. NO REVISION OPERATIVE NOTE HAS BEEN PROVIDED. LITIGATION PAPERS ALLEGE THE PATIENT HAD PAIN AND A LUMP AND THAT "THE TOP OF IMPLANT NEEDS REPLACED". AT THE TIME OF THIS REVIEW THERE WAS NO MENTION OF LUMPS OR NEED FOR REVISION IN THE MEDICAL DOCUMENTS PROVIDED. THE COMPLAINT WAS UPDATED ON:10/30/2015.

Additional Manufacturer Narrative

UDI: (B)(4).

Description of Event or Problem

PPF ALLEGES METAL WEAR, METALLOSIS AND ELEVATED METAL IONS.