BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC FEMORAL STEM

    MDR report key: 7408412 · Received April 9, 2018

    Report

    Report Number
    0001825034-2018-02433
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    September 27, 2017
    Report Date
    May 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED 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. CONCOMITANT MEDICAL PRODUCTS: ITEM #: US157850, ITEM NAME: M2A SHELL, LOT #: 022410, ITEM #: 157444, ITEM NAME: M2A MAGNUM HEAD, LOT #: 309130, ITEM #: 139256, ITEM NAME: M2A TAPER ADAPTOR, LOT #: 520360. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02432.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED REVISION OP NOTES WHICH INDICATED THERE WAS DIFFICULTY REMOVING THE TRUNION. THE REVISION OP NOTES STATE THERE WAS SIGNIFICANT METALLOSIS SURROUNDING THE GREATER TROCHANTER AND PROXIMAL STEM WITH INCOMPLETE FRACTURE NOTED ON THE THINNED GREATER TROCHANTER. THERE WAS A DIFFICULTY OF REMOVING THE TRUNION AND A BONE FRACTURE WAS RECOGNISED POSSIBLY FROM THE METAL REACTION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 1

    IT WAS REPORTED DURING HIP REVISION THAT THE TRUNNION WAS DIFFICULT TO REMOVE. THE STEM AND TRUNNION WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251056 TAPERLOC FEMORAL STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 309130

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention