UNK SHOULDER HUMERAL HEAD GLOBAL

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DEBERNARDIS D, DONNELLY D, BAHEL A, FAVORITO P. TOTAL SHOULDER ARTHROPLASTY FOR GLENOHUMERAL ARTHRITIS ASSOCIATED WITH POSTERIOR GLENOID BONE LOSS: MIDTERM RESULTS OF AN ALL-POLYETHYLENE, POSTERIORLY AUGMENTED, STEPPED GLENOID COMPONENT. J SHOULDER ELBOW SURG. 2025 JAN;34(1):51-61. DOI: 10.1016/J.JSE.2024.03.038. EPUB 2024 MAY 6. PMID: 38719072. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY IS TO REPORT THE MINIMUM 5-YEAR CLINICAL AND RADIOGRAPHIC OUTCOMES OF PATIENTS UNDERGOING ANATOMIC TOTAL SHOULDER ARTHROPLASTY (ATSA) WITH A POSTERIORLY AUGMENTED GLENOID COMPONENT. A TOTAL OF 42 PATIENTS (46 SHOULDERS) UNDERWENT TSA WITH THIS GLENOID COMPONENT (GLOBAL STEPTECH ANCHOR PEG GLENOID; DEPUY SYNTHES, WARSAW, IN, USA) BETWEEN MAY 2011 AND DECEMBER 2015. AMONG THESE, 11 PATIENTS DID NOT RETURN TO THE OFFICE FOR FOLLOW UP, LEAVING 35 SHOULDERS IN 31 PATIENTS. THE MEAN FOLLOW UP WAS MINIMUM 2- AND 5-YEAR FOLLOW-UP. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: GLOBAL STEPTECH ANCHOR PEG GLENOID; DEPUY SYNTHES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT GLOBAL (QTY 2): (N=1) EXPERIENCED POSTERIOR INSTABILITY 22 MONTHS POSTOPERATIVELY AND WAS TREATED WITH CLOSED REDUCTION AND EXTERNAL ROTATION BRACING FOR 6 WEEKS. (N=1) A PATIENT SUBSEQUENTLY UNDERWENT REVISION TO REVERSE TSA AT 6.5 YEARS POSTOPERATIVELY FOR TREATMENT OF SUBSCAPULARIS INSUFFICIENCY. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL HEAD GLOBAL AND UNK SHOULDER GLENOID GLOBAL (QTY 2): (N=1) SUSTAINED A SECOND ATRAUMATIC POSTERIOR DISLOCATION 8 MONTHS LATER AND WAS REVISED TO A REVERSE TSA AT 2.5 YEARS POSTOPERATIVELY. (N=1) EXPERIENCED A SINGLE PERIOPERATIVE ANTERIOR DISLOCATION AND WAS TREATED WITH CLOSED REDUCTION AND SLING IMMOBILIZATION, FOLLOWED BY INITIATION OF PASSIVE THEN ACTIVE-ASSISTED ROM. THIS PATIENT WAS FOLLOWED FOR 3 YEARS POSTOPERATIVELY AND HAD NOT UNDERGONE ADDITIONAL SURGERY DURING THAT TIME PERIOD. PROS AT 3-YEAR FOLLOW-UP INCLUDED A VAS PAIN SCORE OF 5.0, WOOS OF 30, AND SF-36 PCS AND MCS OF 27.3 AND 45.8, RESPECTIVELY.

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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. 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.