STEMLESS L 40

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). 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. H11 ADDITIONAL NARRATIVE: H3, H6 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 PERFORMED. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE DOCTOR WAS DISPLEASED WITH IMMEDIATE POST-OPERATIVE RADIOGRAPHS AND REACQUIRED NEW RADIOGRAPHS. SUBJECT HAD UNDERGONE A REVERSE TOTAL SHOULDER ARTHROPLASTY AND RECEIVED THE INHANCE STEMLESS (TREATMENT) HUMERAL IMPLANT. THE POSTOPERATIVE RADIOGRAPHS INDICATED THAT THE IMPLANT HAS SHIFTED WITHIN THE BONE AND THE DOCTOR HAS DISCUSSED THIS WITH THE SUBJECT. DOCTOR HAS PERFORMED A REVISION SURGERY TO EXPLANT THE INHANCE STEMLESS HUMERAL IMPLANT. AFFECTED SIDE: LEFT SHOULDER.