UNKNOWN SHOULDER HUMERAL HEADS

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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. H11 ADDITIONAL NARRATIVE: ADDED: B5, D10 (CONCOMITANT). CORRECTED: D1, D2A, D2B, D4 (CATALOG).

Description of Event or Problem

CLINICIAN REVIEW OF THE CASEBOOK AND CURRENT ADVERSE EVENT AD 30 SEP 2025: ¿ THE FIRST EVENT OCCURRED ON (B)(6) 2025, PAGE 51 IN THE CASEBOOK, INVOLVED ALL PRODUCTS BEING REVISED, AND ONLY COMPETITOR BRAND (PALACOS) BONE CEMENT HAVING BEEN IDENTIFIED BY THE CLINICAL SITE AS HAVING BEEN USED AS AN IMPLANT FOR TREATMENT (PAGE 58 OF THE CASEBOOK)¿THIS STRONGLY SUGGESTS A SPACER FOR TREATMENT OF THE INFECTION. THIS FIRST REVISION EVENT WAS CAPTURED IN (B)(4) WITH REMOVAL OF ALL SHOULDER IMPLANTS. NO SHOULDER IMPLANTS WERE REPORTEDLY RE-IMPLANTED AT THAT TIME PER THE CASEBOOK EXCEPT THE COMPETITOR BONE CEMENT. ¿ THEN ON (B)(6) 2025, THERE WAS ANOTHER SHOULDER REVISION, PAGE 19 IN THE CASEBOOK, WITH STATED REMOVAL OF AN UNIDENTIFIED STEM, CUP, AND HEAD/GLENOSPHERE. OTHER THEN THAT INFORMATION, NO OTHER PRODUCT DETAILS OF REVISED PRODUCTS WAS PROVIDED. PRODUCTS RE-IMPLANTED ARE PERMANENT REVERSE SHOULDER IMPLANTS, NOT THE TYPE USED IN A SPACER (SEE PAGE 26 ¿ 45 IN THE CASEBOOK)¿SO THEREFORE, THIS REVISION EVENT APPEARS TO BE THE STAGE 2 OF A TWO STAGED PROCEDURE TO TREAT INFECTION, WITH THE STAGE 1 PROCEDURE HAVING OCCURRED ON (B)(6) 2025, WHEN WHAT SEEMS LIKE A SPACER WAS IMPLANTED AS TREATMENT. (B)(6) 2025 SOUNDS LIKE COMPLETION OF TREATMENT WITH NO ALLEGATIONS MADE AGAINST ANY DEPUY PRODUCTS, JUST REMOVAL OF AN UNKNOWN SPACER. ¿ THE CASEBOOK DOES NOT PROVIDE ANY PRODUCT DETAILS ABOUT ANY DEPUY PRODUCTS HAVING BEEN IMPLANTED AS PART OF TREATMENT FOR THE (B)(6) 2025 REVISION. THE ONLY PRODUCT INFORMATION PROVIDED WAS FOR THE COMPETITOR BRAND (PALACOS) BONE CEMENT. ¿ THE CURRENT REVISION FOR INFECTION ON (B)(6) 2025 HAD REMOVAL OF AN UNKNOWN STEM, CUP, AND HEAD/GLENOSPHERE¿THESE THREE PRODUCTS ARE WHAT WOULD ROUGHLY BE REQUIRED FOR CONSTRUCTION OF A SPACER AND WOULD BE REMOVED IN A STAGE 2 OF TWO STAGED REVISION. ¿ AT THIS TIME, PRODUCT DETAILS ARE UNAVAILABLE FOR THE STEM, CUP, AND HEAD/GLENOSPHERE ARE THAT WERE REMOVED FOR THE (B)(6) 2025 REVISION. IT CANNOT BE RULED OUT THAT THEY MIGHT BE DEPUY PRODUCTS. BUT THEY ARE CURRENTLY UNKNOWN. THE ONLY PRODUCTS IDENTIFIED CLEARLY AS DEPUY PRODUCTS ARE THOSE IMPLANTED AS PART OF TREATMENT (ON PAGES 26 ¿ 45 OF THE CASEBOOK). ¿ THE THREE REMOVED UNKNOWN PRODUCTS, IDENTIFIED FOR THIS EVENT AS AN UNK SHOULDER HUMERAL STEM, UNK SHOULDER HUMERAL HEAD, AND AN UNK SHOULDER GLENOID, WILL CAPTURE THE REMOVAL OF AN ANTIBIOTIC SPACER. CONSERVATIVELY, THREE ARE REQUIRED FOR A FUNCTIONAL SPACER, AND THE CASEBOOK INDICATED THREE PRODUCTS WERE REMOVED FOR THE (B)(6) 2025 REVISION. THE THREE SPACER PRODUCTS WILL BE TREATED AS NON-PRODUCT ISSUE IMPACTED PRODUCTS, AS THERE ARE NO ALLEGATIONS MADE AGAINST ANTIBIOTIC SPACERS FOR TREATMENT OF INFECTION. ¿ IF NEW INFORMATION BECOMES AVAILABLE FROM THE CLINICAL STUDY SITE, THEN IMPACTED PRODUCTS AND CODING MAY BE UPDATED AT THAT TIME.

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. H3, H6: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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 DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

SUBJECT ID: (B)(6) STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION DUE TO INFECTION DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025 DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: SHOULDER REVISION, DEPUY SYNTHES COMPONENTS REMOVED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # ==>(B)(4). ADDITIONAL INFORMATION DETERMINED THIS WAS A STAGE 2 REVISION OF AN ANTIBIOTIC SPACER IMPLANTS ARE TYPICALLY REVISED FOLLOWING THE COMPLETION OF THE FIRST STAGE IN A TWO-STAGE REVISION TO ADDRESS INFECTION. THERE ARE NO REPORTED ALLEGATIONS AGAINST THESE PRODUCTS. DEPUY SYNTHES JOINT RECONSTRUCTION DOES NOT CONSIDER THIS FAILURE TO BE A SERIOUS INJURY AT THIS TIME. FURTHER UPDATES WILL ONLY BE PROVIDED IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE REGULATORY DETERMINATION.