BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER

    MDR report key: 7106307 · Received December 11, 2017

    Report

    Report Number
    0001822565-2017-08363
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 14, 2017
    Report Date
    September 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWT
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT: 0100001003, CLS DBL OFS RASP HDL LT, 11682241; 780038, BALL-HEAD IMPACTOR ATTACHMENT, 11682241. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A 40MM VERSYS FEMORAL HEAD PROVISIONAL WAS RETURNED FOR EVALUATION. AS RETURNED, DAMAGE IS SEEN IN THE CONICAL TAPER, OUTER SPHERE, AND BOTTOM SURFACE. DAMAGE IS TOO SEVERE FOR DIMENSIONAL ANALYSIS. DEVICE HISTORY RECORD 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 THAT THE PROVISIONAL HEAD WAS STUCK ON THE DEFINITIVE STEM IN THE PATIENT. NO HARM CAME TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883535 FEMORAL HEAD PROVISIONAL 12/14 NECK TAPER PROSTHESIS, HIP HWT ZIMMER BIOMET, INC. N/A 61867168

    Patients

    Seq Age Sex Outcome Treatment
    1