BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED LINER

    MDR report key: 7405312 · Received April 6, 2018

    Report

    Report Number
    0001825034-2018-01991
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    December 29, 2016
    Report Date
    April 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK030047
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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) CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 14-107018, ITEM NAME: FREEDOM CONSTRAINED HEAD, LOT #: 822460. ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN CUP, LOT #: UNKNOWN. ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN STEM, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01992. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD 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 UNDERWENT HIP REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247204 FREEDOM CONSTRAINED LINER PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 090800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R