BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAIN HEAD

    MDR report key: 7791165 · Received August 16, 2018

    Report

    Report Number
    0001825034-2018-08161
    Event Type
    Injury
    Date Received
    August 16, 2018
    Report Date
    September 20, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED XRAYS WHICH INDICATED SUPERIOR DISLOCATION OF THE FEMORAL COMPONENT OF A LEFT TOTAL HIP ARTHROPLASTY. MILD OSTEOPENIA WAS PRESENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES - G7 FREEDOM CONSTRAIN LINER # ITEM 010000987 LOT UNK; G7 OSSEOTI MULTIHOLE # ITEM 110010271 LOT 3758822; UNK ARCOS MODULAR STEM; G7 SCREW # ITEM 010001002 LOT 3031992; G7 SCREW # ITEM 010001001 LOT 3054977. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-08162. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630851 FREEDOM CONSTRAIN HEAD PROSTHESIS HIP KWZ ZIMMER BIOMET, INC. 860560

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention