BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 7229653 · Received January 30, 2018

    Report

    Report Number
    0002648920-2018-00069
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    October 17, 2014
    Report Date
    May 17, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK95337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT CURRENTLY REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00811400000 ITEM NAME: CPT FEMORAL STEM LOT #: 60352485, ITEM NUMBER: 00-6200-050-22 ITEM NAME: SHELL POROUS WITH CLUSTER HOLES LOT #: 60364979, ITEM NUMBER: 00-6105-050-28 ITEM NAME: TRILOGY LINER LOT #: 60373580. FOREIGN COMPLAINT SOURCE, COMPLAINT WAS REPORTED BY (B)(4). MULTIPLE REPORTS SUBMITTED: 0002648920 - 2018 - 00068, 0002648920 - 2018 - 00070, 0002648920 - 2018 - 00071.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED SURGICAL NOTES. 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.

    Additional Manufacturer Narrative · 1

    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 LOST GREATER THAN 1250 ML OF BLOOD DURING A REVISION PROCEDURE. NO INTERVENTION WAS REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70411 VERSYS FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 60346337

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other