BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 9617936 · Received January 22, 2020

    Report

    Report Number
    0002648920-2020-00038
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    November 9, 2017
    Report Date
    January 21, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: REF 00-6200-048-22 LOT 62176409 SHELL, REF 00-6250-065-25 LOT 62227303 SCREW, REF 00-6310-048-32 LOT 62202324 LINER, REF 00-7713-007-00 LOT 62207765 M/L STEM, REF 00-7848-013-00 LOT 62163622 TAPER ADAPTER. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2019 - 03408. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT UNDERWENT AN INITIAL THA AND NO COMPLICATIONS WERE NOTED. 5 YEARS LATER PATIENT PRESENTED WITH PAIN AND INCREASED CHROMIUM LEVELS(VALUES NOT PROVIDED).INCREASE IN SOFT TISSUE REACTION AND METALLOSIS AT THE HEAD-NECK INTERFACE WERE NOTED. HEAD, NECK AND SHELL WERE REMOVED AND STEM WAS WELL-FIXED AND LEFT IN PLACE. THE REVISION OCCURRED APPROXIMATELY 5 YEARS AFTER THE INITIAL SURGERY. POST-REVISION LABORATORY VALUES ON SHOWED A CHROMIUM LEVELS OF 4.2 AND DECREASED TO 3.0 TWO DAYS LATER. DEVICE HISTORY RECORD (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 PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO PAIN, ELEVATED METAL IONS, AND SOFT TISSUE REACTION AS NOTED ON IMAGING. DURING THE REVISION, METALLOSIS WAS NOTED AROUND THE HEAD-NECK INTERFACE. ALL COMPONENTS BUT THE STEM WERE REVISED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80845 FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 62240313

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R