BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC FEMORAL HEAD

    MDR report key: 6374651 · Received March 2, 2017

    Report

    Report Number
    3002806535-2017-00103
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    January 11, 2017
    Report Date
    June 6, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE REPORTED FEMORAL HEAD FRACTURE CAN BE CONFIRMED AS THE COMPONENT WAS RECEIVED IN FIVE LARGE PIECES AND MULTIPLE SMALLER PIECES. A POINT OF CRACK INITIATION WAS FOUND AT THE TIP OF THE TAPER ENGAGEMENT ON THE SIDE WITH LESS METAL TRANSFER. IT WAS REPORTED THAT THE PATIENT FELL AND THAT CONSEQUENTLY THE HEAD BURST. DETAILS REGARDING THE PATIENT¿S HEIGHT AND WEIGHT HAVE NOT BEEN PROVIDED HOWEVER A FALL WOULD LIKELY HAVE PLACED THE COMPONENTS UNDER UNUSUALLY HIGH STRESSES. THEREFORE IT IS LIKELY THAT PATIENT FACTORS CONTRIBUTED TO THE FAILURE OF THE COMPONENTS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THE REPORTED DEVICE IS SIMILAR TO A DEVICE MANUFACTURED AT ZIMMER BIOMET (B)(4) UNDER 510K NUMBER K082996.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY SIX MONTHS POST-IMPLANTATION DUE TO PAIN AND FRACTURE OF THE FEMORAL HEAD AFTER A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154795 BIOLOX DELTA CERAMIC FEMORAL HEAD PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2016041263

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R