BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 36MM STD NK

    MDR report key: 8267246 · Received January 22, 2019

    Report

    Report Number
    0001825034-2019-00250
    Event Type
    Injury
    Date Received
    January 22, 2019
    Date of Event
    January 14, 2019
    Report Date
    August 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K061312
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 193011, ECHO B-MTRC MP FP SO 11, 692330. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. UPON VISUAL INSPECTION THE HEAD HAD FRACTURED. DEVICE HISTORY RECORDS (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. RESULTS OF MATERIAL ANALYSES: TITANIUM IS DETECTED AS THE DOMINATING ELEMENT OF BOTH METAL TRANSFER PATTERNS, BESIDE THE CERAMIC MATERIAL. IT CAN BE CONCLUDED THAT BOTH PATTERS OF METAL TRANSFER WERE GENERATED BY CONTACT WITH THE METAL STEM. IRON AND NICKEL ARE DETECTED AS DOMINATING ELEMENTS, BESIDE THE CERAMIC MATERIAL. A LINE PATTERN OF DEBRIS AT THE PROXIMAL TAPER END CONTAINS CARBON. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL PROCEDURE THE CERAMIC HEAD IMPLANT SPLIT IN HALF. NO EXTRA FORCE AS GIVEN TO IMPLANT TO IMPACT. ALL THE FRAGMENTS WERE GATHERED AND A NEW HEAD WAS IMPLANTED. A POST OP EXTRA SHOWED MORE OF THE IMPLANT STILL IN THE PATIENT. THE PATIENT WAS THEN BROUGHT BACK IN TO SURGERY TO REMOVE THE LEFT OVER IMPLANT FRAGMENTS. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60308 CER BIOLOXD MOD HD 36MM STD NK PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 2968724

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R