BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTRAINED MODULAR HEAD

    MDR report key: 7751301 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-04503
    Event Type
    Injury
    Date Received
    August 6, 2018
    Report Date
    August 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). CONCOMITANT MEDICAL PRODUCTS: 11-107424 - FREEDOM RINGLOC CONSTRAINED LINER - 256700, 150410 - OSS TIBIAL POLY BEARING 12MM ¿ 576530, 150478 ¿ OSS POLY LOCK PIN ¿ 835360, 150477 - OSS POLY FEMORAL BUSHINGS 2PK ¿ 707650, 150493 - OSS REINFORCED YOKE ¿ 607680, 150423 - OSS MOD TIB BASEPLATE 75MM - 950750. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. X-RAYS WERE RECEIVED AND THE REVIEW STATES THAT OVERALL FIT AND ALIGNMENT AT JOINT LEVEL WERE APPROPRIATE, AND BONES WERE OSTEOPENIC. THE DISTAL COMPONENT OF THE FEMORAL COMPONENT WAS NOT INCLUDED ON THE IMAGES. THERE ARE NO SIGNS OF LOOSENING, WEAR, RADIOLUCENCY, SUBSIDENCE, POLY WEAR DEBRIS, DISSOCIATION OF IMPLANTS, CORROSION OR OSTEOLYSIS. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT IS STILL IMPLANTED IN THE PATIENT. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04505.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING CONSIDERED FOR REVISION AT AN UNKNOWN AMOUNT OF TIME POST INITIAL HIP ARTHROPLASTY IN ORDER TO ADD LENGTH TO THE PROXIMAL FEMUR. THE HEAD AND LINER WERE BEING CONSIDERED TO BE REPLACED, HOWEVER NO KNOWN ADVERSE EVENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595456 FREEDOM CONSTRAINED MODULAR HEAD PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. NI 181400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN LINER| UNKNOWN LINER