BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM

    MDR report key: 4817801 · Received June 2, 2015

    Report

    Report Number
    1822565-2015-00821
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    April 29, 2015
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Removal / Correction Number
    Z-0323-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTO WITHIN THE FAILURE ANALYSIS THAT WAS PROVIDED SHOWED THAT THE STEM HAD FRACTURED JUST DISTAL OF THE PROXIMAL BODY. THE FAILURE ANALYSIS STATED THAT THE STEM HAD FRACTURED DUE TO FATIGUE. THE MFG RECORDS HAVE BEEN REVIEWED AND NO ANOMALIES HAD BEEN FOUND. THIS DEVICE HAS BEEN IN VIVO FOR APPROX 2 YEARS, 8 MONTHS. THESE DEVICES HAVE BEEN USED IN THE TREATMENT OF THE PT. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY MAY BE RELATED TO THE ISSUE FOR WHICH ZIMMER OF ZMR POROUS REVISION HIP PROSTHESIS AND ZMR REVISION TAPER HIP PROSTHESIS IN OCTOBER 2011. A FIELD ACTION WAS CONDUCTED ON OCTOBER 24, 2011; (182565-08/26/2011-001C) IN WHICH ZIMMER UPDATED THE ASSOCIATED LABELING TO PROVIDE FURTHER INSTRUCTIONS, PARTICULARLY AS IT RELATES TO ENSURING FULL PROXIMAL SUPPORT IS ACHIEVED. MFG RECORDS FOR THE STEM AND PROXIMAL BODY WERE REVIEWED AND FOUND CONFORMING AT THE TIME OF MANUFACTURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). OTHER DEVICES USED: CATALOG #00999302045, ZMR HIP SYSTEM FEMORAL BODY, AND LOT #60426054. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO A FRACTURED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355702 ZMR HIP SYSTEM FEMORAL STEM KWZ ZIMMER, INC. 60227290

    Patients

    Seq Age Sex Outcome Treatment
    1