CONTROL CABLE W/CABLE SLEEVE

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOSS OF FIXATION TO THE OSTEOTOMY IS WHAT LED TO THE POOR PATELLAR TRACKING. IMPLANTS WERE PERFORMING AS EXPECTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: B5, D10 (CONCOMITANT), H4. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A RECORDS EVALUATION (MRE) WAS NOT PERFORM AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

Description of Event or Problem

PATIENT'S PATELLA IS NOT TRACKING WELL. PATIENT IS BROUGHT TO THE OPERATING ROOM AND THE TIBIAL TUBERCLE OSTEOTOMY, THAT WAS PERFORMED TO TIGHTEN HIS EXTENSOR MECHANISM, WAS FOUND TO HAVE LOST FIXATION ONCE AGAIN. THIS HAD OCCURRED AFTER HIS INITIAL PROCEDURE AS WELL. THE CABLES WERE STILL IN PLACE; HOWEVER, THEY HAD TO BE REMOVED TO REATTACH THE OSTEOTOMY IN THE APPROPRIATE POSITION. SURGEON CHOSE TO ADJUST THE ROTATION OF THE FEMORAL COMPONENT. IN AN ATTEMPT TO DO SO, THE ENTIRE FEMORAL CONSTRUCT WAS REMOVED, AS IT HAD ONLY BEEN PLACE FOR A FEW WEEKS. A NEW STEM, SLEEVE, ADAPTER AND INSERT WERE PLACED, WHILE REUSING THE SAME DISTAL FEMORAL COMPONENT. WIRES WERE PLACED THROUGH THE TIBIA AND INTO THE OSTEOTOMY TO SECURE FIXATION. ADDITIONALLY, A CABLE WAS PLACED TO ADD ADDITIONAL COMPRESSION OF THE OSTEOTOMY TO INCREASE THE CHANCE OF HEALING. NO PATIENT HARM OCCURRED AND NO DELAY WAS EXPERIENCED. NO ALLEGATION WAS MADE AGAINST ANY COMPONENT, SIMPLY REPLACED IN THE HOPE OF ENHANCING THE CHANCE OF INGROWTH FOR LONG TERM FIXATION. PATIENT WAS PLACED IN A LONG LEG CAST IN AN EFFORT TO PROTECT THE HEALING OF THE OSTEOTOMY REPAIR, AS THE BRACE HE HAD BEEN IN AFTER EACH OF THE PREVIOUS SURGERIES HAD NOT BEEN EFFECTIVE IN DOING SO. THIS SUGGESTS NON-COMPLIANCE WITH POST OPERATIVE ORDERS. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.