BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E1 44-36 STD +3 HMRL BRG

    MDR report key: 7324631 · Received March 8, 2018

    Report

    Report Number
    0001825034-2018-01790
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    August 3, 2017
    Report Date
    March 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK113121
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: 115375 COMP RVS TRAY +5MM CO 44MM 029050; 106021 RINGLOC+ REPLACEMENT RING SZ21 772120. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION REVEALED LOCKING RING WAS SEVERELY BENT AND DINGED; TRAY TAPER SCRATCHED; AND POLY HAD SLIGHT NICKS AND SCRATCHES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING INITIAL REVERSE SHOULDER SURGERY, THE POLY WAS NOT ABLE TO ASSEMBLE WITH THE TRAY. EVEN AFTER TRYING TO USE A NEW LOCKING RING WITH THE POLY, STILL IT WONT ASSEMBLE WITH THE TRAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166380 E1 44-36 STD +3 HMRL BRG PROTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 633410

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR