BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD 36MM DIAMETER BEARING

    MDR report key: 20333527 · Received September 30, 2024

    Report

    Report Number
    0001822565-2024-03099
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    August 31, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00887868231490
    PMA / PMN Number
    K181611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 110031399, MINI STANDARD THICKNESS +0MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY, LOT # 66496129. CATALOG #: 113628, COMP PRIMARY STEM 8MM MINI, LOT # 66255332. CATALOG #: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR, LOT # 66535816. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE HAS BEEN REQUESTED BUT NOT RETURNED BY HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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 WAS REPORTED THAT A PATIENT WAS PRESENTED IN THE SURGEON'S OFFICE WITH A DISLOCATED SHOULDER. DETAILS OF HOW THIS OCCURRED WERE UNCLEAR. THE HUMERAL STEM, TRAY, AND POLYETHYLENE INSERT WERE REVISED. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963480 STANDARD 36MM DIAMETER BEARING EXTREMITY IMPLANT KWS ZIMMER BIOMET, INC. N/A 66638022 00887868231490

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization| R DUE H11