BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAPERLOC POROUS FEMORAL STEM

    MDR report key: 8923524 · Received August 22, 2019

    Report

    Report Number
    0001825034-2019-03658
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 29, 2014
    Report Date
    November 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K101336
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. REVISION OPERATIVE RECORDS WERE REVIEWED AND IDENTIFIED THE FEMORAL HEAD WAS ATTEMPTED AT BEING EXTRACTED AND WAS NOT ABLE TO BE. THE FEMORAL CALF WAS ABLE TO BE EXTRACTED AND THEN THE METAL CUTTING BUR WAS REQUIRED TO SPLIT THE FEMORAL HEAD INSERT. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #US157856, M2A MAG CUP, LOT #: 593890. ITEM #:157450, M2A MAG HEAD, LOT #: 527080. ITEM #: 139256, M2A MAG TPR ADAPTER, LOT #: 871550. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2019-03734.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION PROCEDURE THE HEAD WOULD NOT DISENGAGE FROM THE STEM. NO HARM OR INJURY TO PATENT NOTED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716092 TAPERLOC POROUS FEMORAL STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 116080

    Patients

    Seq Age Sex Outcome Treatment
    1