BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 7292184 · Received February 23, 2018

    Report

    Report Number
    0002648920-2018-00109
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    August 18, 2016
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001822565-2018-00788. CONCOMITANT MEDICAL PRODUCTS: 00633405028 TRILOGY LONGEVITY CONST LINERS ; LOT K071718 UNKNOWN PART/LOT; ACETABULAR CUP. UNKNOWN PART/LOT; FEMORAL STEM. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 THAT THE PATIENT EXPERIENCED DISLOCATION AND HAD A CLOSED REDUCTION APPROXIMATELY TWENTY-SIX (26) MONTHS FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137071 COCR FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. 62389271

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R