BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SHOULDER HUMERAL STEM DELTA XTEND

    MDR report key: 22285089 · Received June 18, 2025

    Report

    Report Number
    1818910-2025-10010
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    September 20, 2024
    Manufacturer
    DEPUY IRELAND
    Product Code
    HSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11: 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. H3, H6: 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: FRASER AN, WAGLE TM, KARLBERG AC, MADSEN JE, MELLBERG M, LIAN T, MADER S, EILERTSEN L, APOLD H, LARSEN LB, PRIPP AH, FJALESTAD T. REVERSE SHOULDER ARTHROPLASTY IS SUPERIOR TO PLATE FIXATION FOR DISPLACED PROXIMAL HUMERAL FRACTURES IN THE ELDERLY: FIVE-YEAR FOLLOW-UP OF THE DELPHI RANDOMIZED CONTROLLED TRIAL. J BONE JOINT SURG AM. 2024 NOV 6;106(21):1945-1956. DOI: 10.2106/JBJS.23.01431. EPUB 2024 SEP 20. PMID: 39303024. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THE DELPHI MULTICENTER, SINGLE-BLINDED RANDOMIZED CONTROLLED TRIAL WAS TO CONDUCT A HIGH-LEVEL INVESTIGATION OF OPERATIVE TREATMENT OF PROXIMAL HUMERAL FRACTURES IN THE ELDERLY, AND THE HYPOTHESIS WAS THAT RTSA WOULD RESULT IN A BETTER CLINICAL OUTCOME COMPARED WITH OPEN REDUCTION AND INTERNAL FIXATION (ORIF). A TOTAL OF 124 PATIENTS WERE INCLUDED IN THE STUDY. 64 PATIENTS WHO HAD BEEN ALLOCATED TO THE RTSA (DELTA XTEND; DEPUY SYNTHES) GROUP AND 60 WHO HAD BEEN ALLOCATED TO THE ORIF (PHILOS; DEPUY SYNTHES) GROUP. THE MEAN AGE (AND STANDARD DEVIATION) WAS 75.2 ± 6.3 YEARS (RANGE, 64.8 TO 85.8 YEARS), 90% OF THE PATIENTS WERE FEMALE, AND 56% HAD A TYPE-C2 FRACTURE (SEE APPENDIX TABLE 1). AT THE TIME OF THE 5-YEAR FOLLOWUP, 65 PATIENTS (39 IN THE RTSA GROUP AND 26 IN THE ORIF GROUP) WERE AVAILABLE FOR CLINICAL TESTING. AN ADDITIONAL 6 PATIENTS (5 IN THE RTSA GROUP AND 1 IN THE ORIF GROUP) ANSWERED QUESTIONS REGARDING PATIENT-REPORTED OUTCOME MEASURES BY MEANS OF A TELEPHONE INTERVIEW. FOURTEEN PATIENTS IN THE RTSA GROUP DROPPED OUT OF THE STUDY (3 HAD COGNITIVE IMPAIRMENT AND 11 GAVE NO REASON). TWENTY-FOUR PATIENTS IN THE ORIF GROUP DROPPED OUT OF THE STUDY (4 HAD COGNITIVE IMPAIRMENT AND 20 GAVE NO REASON). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES DELTA XTEND. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT DELTA XTEND (QTY 18). 2 PATIENTS HAD NERVE INJURY (TRANSIENT). NO INTERVENTION PROVIDED. 2 PATIENTS HAD DEEP WOUND INFECTION. NO INTERVENTION PROVIDED. 6 PATIENTS HAD PERIPROSTHETIC FRACTURE OR FRACTURE DISTAL TO PLATE. 1 PATIENT SUSTAINED A PERIOPERATIVE GLENOID FRACTURE DURING PRIMARY RTSA SURGERY AND THEREFORE RECEIVED TREATMENT WITH HEMIPROSTHESIS INSTEAD OF RTSA. 1 PATIENT HAD GLENOHUMERAL DISLOCATION CAUSED BY A FALL OR MINOR TRAUMA TREATED WITH CLOSED REDUCTION. 2 REVISIONS WITH CHANGING OF THE PLASTIC LINER BECAUSE OF PAIN WITHOUT FINDINGS SUGGESTIVE OF INFECTION. 1 REVISION PLATING OF A PERIPROSTHETIC FRACTURE. 1 REVISION OF HEMI-ARTHROPLASTY. 2 OTHER REVISIONS. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL STEM DELTA XTEND (QTY 1). 1 PATIENT HAD IMPLANT LOOSENING WHERE THE PATIENT DECLINED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640784 UNK SHOULDER HUMERAL STEM DELTA XTEND SHOULDER HUMERAL STEM HSD DEPUY IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention