BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD ST. 9X115 W/ALIGN HOLE W/ALN HOLE

    MDR report key: 15626946 · Received October 18, 2022

    Report

    Report Number
    0001825034-2022-02312
    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
    00880304204492
    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). (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 113763 LOT: 411770 BIO-MOD HUM HEAD 44DIAX15MM 15MM. PART: 113849 LOT: 363710 BIO-MOD GLEN 4MM ALL POLY SMAL. 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 -02315.

    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
    2482706 BIO-MOD ST. 9X115 W/ALIGN HOLE W/ALN HOLE PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. 11-113705 438620 00880304204492

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention