BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER METAGLENE

    MDR report key: 19585078 · Received June 21, 2024

    Report

    Report Number
    1818910-2024-13594
    Event Type
    Injury
    Date Received
    June 21, 2024
    Report Date
    June 21, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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 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. H6: COMPONENT CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (G07002) USED TO CAPTURE NO FINDINGS AVAILABLE. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HOLSCHEN M, AMAZIANE Y, MEYER L, GALAL Y, BOCKMANN B, SCHULTE TL, STEINBECK J. CONVERTING TO REVERSE SHOULDER ARTHROPLASTY FROM PRIMARY ANATOMIC SHOULDER ARTHROPLASTY AND FRACTURE HEMIARTHROPLASTY: A RADIOGRAPHIC AND CLINICAL OUTCOME ANALYSIS AT 8-YEARS. EUR J ORTHOP SURG TRAUMATOL. 2024 MAY;34(4):2193-2200. DOI: 10.1007/S00590-024-03916-8. EPUB 2024 APR 5. PMID: 38578440. OBJECTIVE/METHODS/STUDY DATA: INTRODUCTION: REVISION SHOULDER ARTHROPLASTY CAN BE CHALLENGING. ONE OF THE MAIN CONSIDERATIONS FOR SURGEONS IS THE TYPE OF IMPLANT THAT WAS PLACED IN THE INITIAL SURGERY. ANATOMIC SHOULDER ARTHROPLASTY (ASA) IS USED FOR CASES OF OSTEOARTHRITIS AS WELL AS FOR FRACTURES OF THE HUMERAL HEAD. HEMIARTHROPLASTY CAN BE USED FOR COMPLEX PROXIMAL HUMERUS FRACTURES. THE PURPOSE OF THIS STUDY IS TO DETERMINE WHETHER THERE IS A DIFFERENCE IN CLINICAL AND RADIOGRAPHIC OUTCOMES BETWEEN PATIENTS THAT FAILED PRIMARY FRACTURE HEMIARTHROPLASTY (FHA), OR ASA FOR OSTEOARTHRITIS AND THEN REQUIRED REOPERATION WITH A CONVERSION TO REVERSE SHOULDER ARTHROPLASTY (RSA). METHODS: PATIENTS WITH FAILED ANATOMIC SHOULDER REPLACEMENT, WHO HAD UNDERGONE CONVERSION TO RSA, WERE ENROLLED AFTER A MEAN FOLLOW-UP OF 107 (85-157) MONTHS. TWO DIFFERENT GROUPS, ONE WITH FAILED ASA IMPLANTED FOR OSTEOARTHRITIS AND ONE WITH FAILED FHA, WERE CREATED. AT FOLLOW-UP PATIENTS WERE ASSESSED WITH STANDARD RADIOGRAPHS AND CLINICAL OUTCOME SCORES. RESULTS: TWENTY-NINE PATIENTS (F = 17, M = 12; 51%) SUFFERED FROM A FAILED ASA (GROUP A), WHILE THE REMAINING 28 PATIENTS (F = 21, M = 74; 49%) HAD BEEN REVISED DUE TO A FAILED FHA (GROUP B). PATIENTS OF GROUP B HAD A POORER CONSTANT SCORE (GROUP A: 60 VS. GROUP B: 46; P = 0.02). ABDUCTION (GROUP A: 115° VS. GROUP B: 89°; P = 0.02) WAS WORSE AFTER CONVERSION OF A FAILED FHA TO RSA IN COMPARISON TO CONVERSIONS OF FAILED ASA. THE MEAN BONE LOSS OF THE LATERAL METAPHYSIS WAS HIGHER IN PATIENTS WITH FAILED FHA (GROUP A: 5 MM VS. GROUP B: 20 MM; P = 0.0). CONCLUSION: THE INITIAL INDICATION FOR ANATOMIC SHOULDER ARTHROPLASTY INFLUENCES THE CLINICAL AND RADIOLOGICAL OUTCOME AFTER CONVERSION TO RSA. CONVERSION OF FAILED FHA TO RSA IS RELATED TO AN INCREASED METAPHYSEAL BONE LOSS, DECREASED RANGE OF MOTION AND POORER CLINICAL OUTCOMES WHEN COMPARED TO CONVERSIONS OF FAILED ASA IMPLANTED FOR OSTEOARTHRITIS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK SHOULDER HUMERAL STEM DELTA XTEND, UNK SHOULDER HUMERAL CUP DELTA XTEND, UNK SHOULDER GLENOSPHERE DELTA XTEND, UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND, UNK SHOULDER METAGLENE, UNK SHOULDER LOCKING SCREW (MINIMUM OF 2) USED 47 TOTAL SHOULDERS OF THE STUDY WHICH ACCOUNTS FOR THE MAJORITY OF THE PARTICIPANTS. OTHER DEVICES THAT WERE USED IN THE STUDY (QTY 10 TOTAL SHOULDERS USED NON DEPUY SYNTHES PRODUCTS): TORNIER: AEQUALIS REVERSE (TORNIER) USED IN 3 SHOULDERS IN THE STUDY; ANATOMICAL SHOULDER REVERSE (ZIMMER) USED IN 4 SHOULDERS IN THE STUDY; AND PROMOS REVERSE (SMITH & NEPHEW) USED IN 3 SHOULDERS IN THE STUDY. THE ARTICLE PROVIDES A LIST OF 13 PATIENTS IN TABLE 5 WITH COMPLICATIONS BUT DOES NOT IDENTIFY WHICH DEVICE MANUFACTURER PRODUCT WAS USED IN EACH PATIENT. THEREFORE, THE EXACT QUANTITIES OF PRODUCTS AND ASSOCIATED COMPLICATIONS CANNOT BE DETERMINED WITHOUT FURTHER CLARIFICATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL STEM DELTA XTEND: QTY UNKNOWN PERIPROSTHETIC FRACTURED TREATED WITH REVISION OF STEM EXCHANGE QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN STEM LOOSENING TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND: QTY UNKNOWN PERIPROSTHETIC FRACTURED TREATED WITH REVISION OF STEM EXCHANGE QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL CUP DELTA XTEND: QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER GLENOSPHERE DELTA XTEND: QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER METAGLENE: QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER LOCKING SCREW: QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER LOCKING SCREW: QTY UNKNOWN INFECTION TREATED WITH REVISION QTY UNKNOWN HEMATOMA TREATED WITH SURGICAL INTERVENTION AND/OR REVISION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103855 UNKNOWN SHOULDER METAGLENE SHOULDER METAGLENE HSD DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention