SROM 9/10 16X11X130 30+4

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6), 2014, THE PRIMARY SURGERY WAS PERFORMED VIA THA FOR OA WITH THE IMPLANTS IN QUESTION. THE PATIENT WAS 66 YEARS OLD AT THE TIME OF SURGERY AND IS NOW 75 YEARS OLD, 9 YEARS AFTER SURGERY. THE PATIENT HAD NOT BEEN SEEN THE DOCTOR FOR THE LAST TWO YEARS. NO BREAKAGE WAS OBSERVED IN THE XRAY TWO YEARS AGO. ON AN UNKNOWN DATE, THE MOST RECENT XRAY REVEALED A FRACTURE AT THE DISTAL PART OF THE STEM (BASE OF THE LEG). THE EVENT DATE IS UNKNOWN. CURRENTLY, THE PATIENT HAS NO SUBJECTIVE SYMPTOMS AND IS UNDER OBSERVATION.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). NO 510K AS DEVICE IS NOT MARKETED IN THE UNITED STATES UNDER THIS PRODUCT CODE, BUT A SIMILAR PRODUCT IS MARKETED IN THE US UNDER A DIFFERENT PRODUCT CODE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT 900550210, LOT 5364622, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. THERE WERE NO SCRAP PARTS ASSOCIATED WITH THIS LOT. THERE WAS NO MATERIAL REPROCESSING REPORTS (MRR) ASSOCIATED WITH THIS LOT. THERE WERE ZERO NON-CONFORMANCES ASSOCIATED WITH THIS LOT. ACCELLENT CERTIFICATE OF COMPLIANCE OF (B)(6) 2013 (PO 5233267) HAS BEEN REVIEWED FOR COMPONENT SROM 9/10 16X11X130 30+4, COMPONENT LOT 6000536, COMPONENT CODE 629199, USED IN THE WORK ORDER 5364622 AND MEETS SPECIFICATIONS. NO DEVIATIONS OR ANOMALIES HAVE BEEN IDENTIFIED DURING THE REVIEW, THAT WOULD BE RELATED TO THE REPORTED EVENT (B)(4). DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED. 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: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE PRODUCT 900550210, LOT 5364622, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.