BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS HUMERAL HEAD 45/15

    MDR report key: 23190036 · Received October 1, 2025

    Report

    Report Number
    1220246-2025-04290
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 17, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B3, G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS A PATIENT-SPECIFIC EVENT AS THE PATIENT UNDERWENT A REVISION SURGERY. PER DFU-0202-4 REV. 0: POST-OPERATIVE PROTOCOL. 1. PATIENTS WHO HAVE UNDERGONE ARTHROPLASTY SHOULD BE ROUTINELY EXAMINED BY THE PHYSICIAN TO MONITOR HEALING, AND POTENTIAL COMPLICATIONS. 2. THE PATIENT MUST BE INSTRUCTED TO IMMEDIATELY INFORM THE SURGEON OF ANY ADVERSE CHANGES TO THE OPERATIVE JOINT. ADDITIONALLY, ANY FALLS OR OTHER IMPACTS TO THE OPERATIVE SITE SHOULD BE REPORTED, SO THAT THE SURGEON CAN ASSESS WHETHER AN ADDITIONAL EXAMINATION IS REQUIRED. 3. AT A MINIMUM, A CONTROL X-RAY SHOULD BE SENT TO THE SURGEON EVERY 12 MONTHS FOR A RADIOLOGIC ASSESSMENT OF THE OPERATIVE JOINT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CLINDEX NOTIFICATION WAS RECEIVED REGARDING A PATIENT LISTED IN THE SHOULDER ARTHROPLASTY REGISTRY. THE PATIENT HAD RETURNED TO THE CLINIC ON (B)(6) 2025 DUE TO PAIN AND FUNCTIONAL LIMITATIONS. A CT SCAN WAS ORDERED AND REVIEWED. BASED ON IMAGING AND CLINICAL EXAMINATION, A ROTATOR CUFF TEAR WAS DIAGNOSED. THE RECOMMENDED TREATMENT WAS REVISION TO REVERSE SHOULDER ARTHROPLASTY, AND SURGERY WAS SCHEDULED FOR (B)(6) 2025. THIS EVENT WAS DETERMINED TO BE UNRELATED TO THE UNIVERS REVERS APEX IMPLANT PLACED ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED ON 9/17/2025: DURING THE INITIAL SHOULDER ARTHROPLASTY, THE FOLLOWING IMPLANTS WERE USED: AR-9100-05S ARTHREX UNIVERS HUMERAL STEM, AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, AND AR-9145-15 ARTHREX UNIVERS HUMERAL HEAD. POSTOPERATIVELY, THE PATIENT EXPERIENCED SYMPTOMS THAT WERE INITIALLY MANAGED WITH CONSERVATIVE MEASURES, INCLUDING PHYSICAL THERAPY AND NSAID USE AS NEEDED. WHEN SYMPTOMS PERSISTED DESPITE THESE INTERVENTIONS, A CT SCAN WAS PERFORMED, REVEALING SUPRASPINATUS ATROPHY AND A ROTATOR CUFF TEAR. BASED ON THESE FINDINGS, IT WAS DETERMINED THAT REVISION FROM TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY WOULD BE THE MOST APPROPRIATE TREATMENT. THE RSA REVISION PROCEDURE WAS COMPLETED ON (B)(6) 2025. IT WAS NOT CONFIRMED IF ANY PRODUCTS WERE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED ON 9/25/2025: IT WAS CONFIRMED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025 DURING WHICH AN AR-9100-05S ARTHREX UNIVERS HUMERAL STEM, AR-9106-01 ARTHREX UNIVERS VAULTLOCK GLENOID, AND AR-9145-15 ARTHREX UNIVERS HUMERAL HEAD WERE REMOVED. THE SURGERY WAS COMPLETED USING NEW ARTHREX IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105679 UNIVERS HUMERAL HEAD 45/15 PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. UNIVERS HUMERAL HEAD 45/15 150069110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other