BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPELAND THN SHL COCR/HA HUMS3

    MDR report key: 22916432 · Received August 28, 2025

    Report

    Report Number
    3002806535-2025-00434
    Event Type
    Injury
    Date Received
    August 28, 2025
    Report Date
    December 16, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWS
    PMA / PMN Number
    NOT CLEARED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, B7, D2A, D4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS CORRECTION REPORT PREVIOUSLY REPORTED MFR REPORT NUMBER - 0001825034-2025-02629 UNDER MEDWATCH FACILITY WARSAW BIOMET - (B)(4). LEGAL MANUFACTURER DETAILS CORRECTED AND CURRENT REPORT UNDER MEDWATCH FACILITY UK - (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D6A: EXACT DATE UNKNOWN; HOWEVER, SOMETIME IN (B)(6) 2015. E1: FULL ESTABLISHMENT ADDRESS: (B)(6). (B)(6) HOSPITAL. G2: FOREIGN - EVENT OCCURRED IN THE UK. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K080642. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - HEAD. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION ON AN UNKNOWN DATE APPROXIMATELY TEN (10) YEARS AGO. SUBSEQUENTLY, THE PATIENT IS PLANNED TO UNDERGO A REVISION PROCEDURE ON AN UNKNOWN DATE TO RECEIVE A PMI REVERSE SHOULDER DUE TO PAIN. IT IS NOTED THE SOURCE OF THE PAIN IS UNKNOWN AT THIS TIME BUT IS SUSPECTED TO EITHER BE CONTRIBUTED BY THE PATIENT'S SIGNIFICANT CUFF TENDINOPATHY OR GLENOID BONE WEAR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235704 COPELAND THN SHL COCR/HA HUMS3 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS BIOMET UK LTD. 3292881

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other