BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD RGX AUG - LG

    MDR report key: 25258115 · Received May 22, 2026

    Report

    Report Number
    0001825034-2026-01458
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    June 25, 2025
    Report Date
    May 22, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    UDI-DI
    00880304540750
    PMA / PMN Number
    K111746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS IN THE D10 NARRATIVE BELOW. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 110029826 (656680), 211223 (66287804), 211224 (66626556), 211256 (103210). ASSOCIATED PRODUCT INFORMATION: - UNKNOWN CEMENT (UNKNOWN). G2: FOREIGN - EVENT OCCURRED IN DENMARK. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INITIAL LEFT TOTAL HUMERAL ARTHROPLASTY WAS PERFORMED. THE PATIENT SUBSEQUENTLY DEVELOPED A WOUND-HEALING COMPLICATION. APPROXIMATELY TWO AND A HALF MONTHS AFTER THE INDEX PROCEDURE, DEBRIDEMENT OF SOFT TISSUE AND ANTIBIOTIC THERAPY WERE PERFORMED. ALL IMPLANTS REMAINED IMPLANTED. AT ONE-YEAR FOLLOW-UP, THE PATIENT REPORTED BEING SATISFIED. DUE DILIGENCE IS COMPLETE FOR THIS COMPLAINT; IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE, AND TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604563 COMPR SRS MOD RGX AUG - LG PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT ZIMMER BIOMET, INC. 726590 00880304540750

    Patients

    Seq Age Sex Outcome Treatment
    1