BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-H HA/PC 12X165MM T1

    MDR report key: 5304082 · Received December 16, 2015

    Report

    Report Number
    3002806535-2015-04170
    Event Type
    Injury
    Date Received
    December 16, 2015
    Date of Event
    November 19, 2015
    Report Date
    February 2, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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. DATE IMPLANTED - UNKNOWN IF IMPLANTED IN 1995 OR 2006. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K021403.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT - DELTA CERAMIC FEM HD 028/ 0MM, ITEM # 164136, LOT # 1109480. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY IN 1995. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED IN 2006 DUE TO UNKNOWN REASONS. IT WAS FURTHER REPORTED PATIENT UNDERWENT A SECOND REVISION IN (B)(6) 2015 DUE TO FRACTURE OF THE TAPER ADAPTER ON THE FEMORAL STEM. THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL ALLEGED DURING THE REVISION PROCEDURE ON (B)(6) 2015, THE TROCHANTER FRACTURED. THE SURGEON REPAIRED THE FRACTURE WITH A TROCHANTER HOOK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN 1995. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED IN 2006 DUE TO UNKNOWN REASONS. IT WAS FURTHER REPORTED PATIENT UNDERWENT A SECOND REVISION IN (B)(6) 2015 DUE TO FRACTURE OF THE TAPER ADAPTER ON THE FEMORAL STEM. THE FEMORAL STEM AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829010 M-H HA/PC 12X165MM T1 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R