BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD GLEN 4MM ALL-POLY SMAL

    MDR report key: 15626803 · Received October 18, 2022

    Report

    Report Number
    0001825034-2022-02315
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 6, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304214002
    PMA / PMN Number
    K030710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 11-113705, LOT: 438620, BIO-MOD ST. 9X115 W/ALIGN HOLE W/ALN HOLE. PART: 113763, LOT: 411770, BIO-MOD HUM HEAD 44DIAX15MM 15MM. PART: 110019066, LOT: 280000, COMPR VRS BONE & IMPLANT MODEL. PART: 405800, LOT: 684630, COMP. REV SHLDR 9 IN STEINMANN. PART: 405889, LOT: 840220, COMP RVS 2.7MM DIA DRL. PART: 405889, LOT: 840280, COMP RVS 2.7MM DIA DRL. PART: 113632, LOT: 65066752, COMP PRIMARY STEM 12MM MINI. PART: 110031402, LOT: 65362543, HMRL TRAY +3 STD. PART: 110031427, LOT; 65337933, HMRL BEARING 40 MM STD VITE. PART: 110027734, LOT: 279950, COMP VRS IMPLT W MI TPR ADPTR. PART: 110031378, LOT: 513750, VERSA-DIAL TAPER ADAPTOR 25MM. PART: 115399, LOT; 641330R, COMP RVS CNTRL 6.5X45MM ST/RST. PART: 180554, LOT: 241190, COMP LK SCR 3.5HEX 4.75X35 ST. PART: 180555, LOT: 973080, COMP LK SCR 3.5HEX 4.75X40 ST. PART: 180555, LOT: 072240, COMP LK SCR 3.5HEX 4.75X40 ST. PART: 180551, LOT: 729100, COMP LK SCR 3.5HEX 4.75X20 ST. PART: 110030776, LOT: 65411933, 40 MM VERSA-DIAL GLEN STD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 02312.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOR ANATOMIC GLENOID LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483690 BIO-MOD GLEN 4MM ALL-POLY SMAL PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. 113849 363710 00880304214002

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H