BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZMR HIP SYSTEM FEMORAL STEM

    MDR report key: 4663491 · Received April 3, 2015

    Report

    Report Number
    1822565-2015-00504
    Event Type
    Injury
    Date Received
    April 3, 2015
    Date of Event
    May 24, 2013
    Report Date
    November 30, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMMON CLINICAL PRESENTATION AND UNKNOWN ORIGINAL IMPLANTATION LEAVES THE POTENTIAL FOR THIS EVENT TO BE RELATED TO THE LABELING OF ZMR POROUS REVISION HIP PROSTHESIS AND ZMR REVISION TAPER HIP PROSTHESIS IN (B)(6) 2011. A FIELD ACTION WAS CONDUCTED ON OCTOBER 24, 2011 IN WHICH ZIMMER UPDATED THE ASSOCIATED LABELING TO PROVIDE FURTHER INSTRUCTIONS, PARTICULARLY AS IT RELATES TO ENSURING FULL PROXIMAL SUPPORT IS ACHIEVED. HOWEVER, IT IS REPORTED THAT A 32 MM HOODED STELKAST ACETABULAR LINER WAS USED WITH A ZMR FEMORAL BODY REVISION SYSTEM. ZIMMER HAS NOT TESTED THE COMPATIBILITY OF THIS COMBINATION OF DEVICE, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. THEREFORE, A CONCLUSIVE CAUSE FOR THE EVENT DESCRIBED CANNOT BE DETERMINED AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT IS CONFIRMED AS THE RETURNED IMPLANT WAS FRACTURED. THE DISTAL PORTION OF A FRACTURED STEM WAS RETURNED FOR EVALUATION. AS RETURNED, THE PLASMA SPRAY IS SMEARED TOWARDS THE PROXIMAL END WITH A SMALL PORTION MISSING. DEEP GOUGES ARE SEEN RUNNING LENGTH WISE TO THE AXIS OF THE STEM. THIS DAMAGE MOST LIKELY OCCURRED DURING THE REMOVAL PROCESS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IT IS REPORTED THAT A 32 MM HOODED STELKAST ACETABULAR LINER WAS USED WITH A ZMR FEMORAL BODY REVISION SYSTEM. ZIMMER HAS NOT TESTED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. THE RECOMMENDED COMPATIBILITY CHART CAN BE FOUND AT WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED IN THIS EVENT WITH THE INFORMATION 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 IS REPORTED THE PATIENT WAS REVISED TO ADDRESS A STEM FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220563 ZMR HIP SYSTEM FEMORAL STEM KWZ ZIMMER, INC. N/A 60418124

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention LOT #60207130