BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-36 STD +3 HMRL BRG

    MDR report key: 17219238 · Received June 28, 2023

    Report

    Report Number
    0001825034-2023-01440
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 5, 2023
    Report Date
    November 15, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304543188
    PMA / PMN Number
    K113121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE VISUAL EXAMINATIONS THE ARTICULATING SURFACE OF THE BEARING HAS SCRATCHES AND DAMAGE. THE FACE OF THE BEARING AND OUTER WALL OF THE BEARING ALSO EXHIBIT DAMAGE. THE BEARING WAS RETURNED ASSEMBLED FLUSH TO THE TRAY WITH NO GAPS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE REPORTED EVENT OF IMPLANT FRACTURE WAS CONFIRMED THROUGH PRODUCT RETURN. THE REPORTED EVENT OF DISLOCATION IS UNABLE TO BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2023 -01439, 0001825034 -2023 -01442. D10: COMP RVS TRAY CO 44MM CAT: 115370 LOT: 821480; COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 837020; COMP PRIMARY STEM 13MM MINI CAT: 113633 LOT: 883710; COMP AUG MINI BSPLT W TPR LG CAT: 110032430 LOT: 64003004; COMP RVS CNTRL 6.5X35MM ST/RST CAT: 115397 LOT: 572130; COMP LK SCR 3.5HEX 4.75X25 ST CAT: 180552 LOT: 603140; COMP LK SCR 3.5HEX 4.75X25 ST CAT: 180552 LOT: 651210; COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 237970; COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 851610. G2: FOREIGN: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY REVERSE SHOULDER REPLACEMENT AND WAS SUBSEQUENTLY REVISED DUE TO DISLOCATION, PAIN AND IMPLANT FRACTURE APPROXIMATELY FIVE YEAR POST IMPLANTATION. THE SURGEON DISCOVERED THAT THE HUMERAL TRAY HAD BROKEN OFF ITS TAPER AND THE TAPER WAS STUCK IN THE STEM. THE SURGEON REMOVED THE TRAY/POLY CONSTRUCT AND THE TAPER. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1571367 E1 44-36 STD +3 HMRL BRG SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. EP-115394 285150 00880304543188

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10