BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL HEAD

    MDR report key: 6980977 · Received October 26, 2017

    Report

    Report Number
    0002648920-2017-00657
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 26, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    PK953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS - ALLOFIT ALLOCLASSIC SHELL 52/I I CATALOG#: 00000004245 ,LOT#: 2882155, AVENIR® MüLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14 CATALOG#: 0106010104 LOT#: 4024135, DURASUL®, ALPHA INSERT, II/32 CATALOG#: 0100013409, LOT#: 2845918. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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

    (B)(4). UNIQUE IDENTIFIER (UDI)# - (B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS BEEN INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED 20 DAYS POST-IMPLANTATION DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND TEMPORARY IMPLANTS WERE PLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760659 COCR FEMORAL HEAD PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 63445154

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R