BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD HUM HEAD 40DIAX15MM

    MDR report key: 15759723 · Received November 9, 2022

    Report

    Report Number
    0001825034-2022-02538
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    March 22, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K030710
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: CATALOG #: 113952, SM HYBRID GLENOID BASE 4MM, LOT # 822820; CATALOG #: 113628, COMP PRIMARY STEM 8MM MINI, LOT # 794210; CATALOG #: PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 103360. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02537.

    Additional Manufacturer Narrative · 0

    (B)(4). PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT AN ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED APPROXIMATELY 8 MONTHS AGO FOR DISLOCATION. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650177 BIO-MOD HUM HEAD 40DIAX15MM EXTREMITIES IMPLANTS HSD ZIMMER BIOMET, INC. N/A 063250

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H