BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 1 PC SHELL 38MMX60MM

    MDR report key: 7107152 · Received December 11, 2017

    Report

    Report Number
    0001825034-2017-10985
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    November 7, 2017
    Report Date
    May 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOLOX DELTA MODULAR CERAMIC HEAD LOT#1620319 ITEM#12-115132, BI-METRIC HIP PRIMARY FEMORAL STEM COLLARLESS/POROUS & HA COATED 17 X 165MM WITH TYPE 1 TAPER LOT#1573983 ITEM#162037. THE REPORTED EVENT WAS CONFIRMED THROUGH REVISION CLINICAL FORM RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    (B)(4). REPORT SOURCE FOREIGN. THE EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED 7 YEARS POST IMPLANTATION DUE TO RISING COBALT AND CHROMIUM IONS AND PAIN. MRI SCAN CONFIRMED ADVERSE REACTIONS TO METAL DEBRIS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883948 M2A 1 PC SHELL 38MMX60MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 168330

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R