UNKNOWN SHOULDER HUMERAL HEADS

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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR SHOULDER REVISION. IT WAS REPORTED THAT PATIENT INITIALLY HAD AN ANATOMIC DEPUY RIGHT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2020. PATIENT DID WELL INITIALLY BEFORE EXPERIENCING A GRADUAL INCREASE IN SHOULDER PAIN AND A FALL IN (B)(6) 2021--MARS CT SCAN WAS NEGATIVE AT THAT TIME. PATIENT EXPERIENCED AN INJURY TO THE SHOULDER AGAIN AND RECEIVED AN OPEN REDUCTION INTERNAL FIXATION OF RIGHT SHOULDER ACROMION (B)(6) 2022. IN FURTHER CLINIC FOLLOW-UP ON (B)(6) 2023, ANOTHER MARS CT SCAN REVEALED THAT PATIENT HAD NOW EXPERIENCED A FULL THICKNESS ROTATOR CUFF TEAR. SINCE LAST CT SCAN, PATIENT HAD RECEIVED SPINAL FUSION SURGERY, AND AN ORIF OF RIGHT PERIPROSTHETIC FEMUR FRACTURE. ON (B)(6) 2024, PATIENT RECEIVED A RIGHT TOTAL SHOULDER REVISION FOR CONVERSION TO A REVERSE TOTAL SHOULDER ARTHROPLASTY FOR PAIN, COMPLETE ROTATOR CUFF TEAR AND PSEUDO-PARALYSIS OF THE RIGHT SHOULDER (JOINT IMPAIRMENT). THE EXISTING HUMERAL STEM WAS PRESERVED, AND HUMERAL HEAD AND PEGGED GLENOID REMOVED. DEPUY REVERSE SHOULDER COMPONENTS WERE IMPLANTED USING THE EXISTING HUMERUS TO RESTORE SHOULDER FUNCTION. THERE WERE NO COMPLICATIONS.