CEMENTRALIZER 13.0

Description of Event or Problem

PATIENT HAS NOW BEEN REVISED TO ADDRESS A CONFIRMED INFECTION WITH EXPLANTATION OF ALL PRODUCTS. THIS INCLUDING THE USE OF AN OPENING FEMORAL OSTEOTOMY TO FACILITATE REMOVAL OF THE FEMORAL STEM. AN ANTIBIOTIC SPACER WAS RE-IMPLANTED TO ADDRESS THE INFECTION. ALL DEVICES ARE CONSIDERED REPORTABLE, GIVEN THAT IT IS NOT POSSIBLE TO RULE-OUT THEIR POSSIBLE CONTRIBUTION, GIVEN THAT THEY PRESENT A SAFE HARBOR FOR INFECTIOUS MICROORGANISMS TO TAKE HOLD.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. NO REVISION HAS BEEN REPORTED. EXAMINATION OF THE PROVIDED X-RAY IMAGES FINDS NOTHING INDICATIVE OF A PRODUCT PROBLEM. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : THE DEVICES HAVE BEEN IMPLANTED FOR MORE THAN EIGHT YEARS AND NO REVISION HAS BEEN REPORTED. IT IS NOT LIKELY AN ERROR IN THE MATERIAL, MANUFACTURING, INSPECTION OR STERILE PROCESSING WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATIONS. A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. NO REVISION HAS BEEN REPORTED. EXAMINATION OF THE PROVIDED X-RAY IMAGES FINDS NOTHING INDICATIVE OF A PRODUCT PROBLEM. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Description of Event or Problem

PATIENT HAS NOW BEEN REVISED TO ADDRESS A CONFIRMED INFECTION WITH EXPLANTATION OF ALL PRODUCTS. THIS INCLUDING THE USE OF AN OPENING FEMORAL OSTEOTOMY TO FACILITATE REMOVAL OF THE FEMORAL STEM. AN ANTIBIOTIC SPACER WAS RE-IMPLANTED TO ADDRESS THE INFECTION. EVENT IS POSSIBLY RELATED TO DEVICE AND NOT RELATED TO PROCEDURE. DATE OF IMPLANT:(B)(6) 2012; DATE OF EVENT: (B)(6) 2021; (RIGHT HIP).