BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER HUMERAL CUP DELTA XTEND

    MDR report key: 22294109 · Received June 19, 2025

    Report

    Report Number
    1818910-2025-10161
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    March 28, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. 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: SUREN C, KOCH MJ, HOFSTETTER S, RAB P, SEEBAUER L. THE IMPACT OF THE UNDERLYING PATHOLOGY AND PREVIOUS SURGERY ON THE LONG-TERM FUNCTIONAL OUTCOMES OF THE DELTA XTEND REVERSE TOTAL SHOULDER ARTHROPLASTY: A PROSPECTIVE COHORT STUDY WITH A MINIMUM FOLLOW-UP OF 11 YEARS. J SHOULDER ELBOW SURG. 2025 MAR 28:S1058-2746(25)00260-5. DOI: 10.1016/J.JSE.2025.02.038. EPUB AHEAD OF PRINT. PMID: 40158876. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS PROSPECTIVE COHORT STUDY WAS TO EVALUATE THE LONG-TERM FUNCTIONAL AND RADIOGRAPHIC OUTCOMES OF THE DELTA XTEND REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA) SYSTEM IN CONTEXT WITH THE UNDERLYING INDICATION FOR SURGERY. A TOTAL OF 108 PATIENTS UNDERWENT DELTA XTEND REVERSE SHOULDER PROSTHESIS IMPLANTATION BETWEEN APRIL AND DECEMBER 2008. AMONG THESE, ONLY 43 PATIENTS (35% WERE MALE; 70.7 ± 8.2 YEARS AT SURGERY) WERE INCLUDED IN THE LONG-TERM FOLLOW-UP. THE MEDIAN FOLLOW-UP WAS OF 12.5 YEARS (RANGE: 11.5-12.6 YEARS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES DELTA XTEND REVERSE TOTAL SHOULDER ARTHROPLASTY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT DELTA XTEND (QTY (B)(4)): A 68-YEAR-OLD MALE PATIENT HAD REVISION (EXCHANGE OF GLENOSPHERE AND LINER) DUE TO CHRONIC INSTABILITY. A 63-YEAR-OLD FEMALE PATIENT HAD REVISION (SEPTIC EXCHANGE) DUE TO LOW-GRADE INFECTION. AN 84-YEAR-OLD FEMALE PATIENT HAD REVISION (SEPTIC EXCHANGE) DUE TO LOW-GRADE INFECTION. A 78-YEAR-OLD MALE PATIENT HAD STRESS FRACTURE OF ACROMION; TREATED WITH ORIF (K-WIRES). A 72-YEAR-OLD MALE PATIENT HAD STRESS FRACTURE OF ACROMION; TREATED WITH ORIF (PLATE). A 73-YEAR-OLD MALE PATIENT HAD PSEUDARTHROSIS OF THE ACROMION AFTER TRAUMATIC REFRACTURE AND WAS TREATED CONSERVATIVELY DUE TO NON-COMPLIANT PATIENT. A 72-YEAR-OLD FEMALE PATIENT HAD ARTHROFIBROSIS; TREATED WITH ARTHROLYSIS, LINER EXCHANGE. A 79-YEAR-OLD FEMALE PATIENT HAD TRAUMATIC FRACTURE OF SCAPULAR SPINE; TREATED WITH ORIF (PLATE). AN 83-YEAR-OLD FEMALE PATIENT HAD POSTOPERATIVE HEMATOMA; TREATED WITH LAVAGE. A 75-YEAR-OLD MALE PATIENT HAD POSTOPERATIVE HEMATOMA; TREATED WITH LAVAGE. ONE PATIENT (MALE, AGED 85 YEARS) EXHIBITED ACROMIAL PSEUDARTHROSIS DUE TO A NEGLECTED TRAUMATIC REFRACTURE FOLLOWING PREVIOUS ORIF WITH PLATE TO TREAT AN ACROMIAL STRESS FRACTURE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT DELTA XTEND (QTY (B)(4)): 14 PATIENTS HAD SCAPULAR NOTCHING: GRADE 1 (N=11) AND GRADE 2 (N=3) AT 11 YEAR FOLLOW-UP. NO INTERVENTION NOTED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL STEM DELTA XTEND AND UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND (QTY (B)(4)): A 66-YEAR-OLD FEMALE PATIENT HAD REVISION (EXCHANGE OF HUMERAL COMPONENT) DUE TO ASEPTIC LOOSENING OF HUMERAL COMPONENT. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER GLENOSPHERE DELTA XTEND AND UNK SHOULDER HUMERAL CUP DELTA XTEND (QTY (B)(4)): A 75-YEAR-OLD FEMALE PATIENT HAD DISLOCATION; TREATED WITH LINER EXCHANGE. AN 85-YEAR-OLD FEMALE HAD DISLOCATION; TREATED WITH CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724560 UNK SHOULDER HUMERAL CUP DELTA XTEND SHOULDER HUMERAL CUP PHX DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention