BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET SHELL

    MDR report key: 18844670 · Received March 6, 2024

    Report

    Report Number
    0001825034-2024-00641
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 26, 2024
    Report Date
    March 5, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2024-00776. D10: CAT #: 650-1065 / CER OPTION TYPE 1 TPR SLEVE -3 / LOT #: 3101857. CAT #: 650-1055 / CER BIOLOXD OPTION HD 28MM / LOT #: 3114759. CAT #: 110031009 / 28MM I.D. 38MM O.D. SIZE C BEARING / LOT #: 65931510. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. UNABLE TO CONFIRM THE COMPLAINT AS NO PRODUCT INFORMATION OR MEDICAL RECORDS WERE PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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 A PATIENT UNDERWENT A REVISION APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO UNKNOWN REASONS. A SHELL, BEARING, HEAD AND TAPER WERE REMOVED AND REPLACED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118545 UNKNOWN BIOMET SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H10 NARRATIVE.