BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TAPERLOC FEMORAL STEM

    MDR report key: 6768121 · Received August 4, 2017

    Report

    Report Number
    0001825034-2017-05939
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    November 3, 2015
    Report Date
    August 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDG
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS DOES NOT CHANGE THE EVALUATION CODE AND CONCLUSION IN PREVIOUS REPORT. 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)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. CONCOMITANT PRODUCTS: UNK, UNKNOWN LINER, UNK; UNK, UNKNOWN CUP, UNK; UNK, UNKNOWN HEAD, UNK. 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. NEBERALL, A. K., BA, ROLFSON, O., MD, RUBASH, H. E., MD, MALCHAU, H., MD, TROELSEN, A., MD, & GREENE, M. E., PHD. (2015). STABLE FIXATION OF A CEMENTLESS, PROXIMALLY COATED, DOUBLE WEDGED, DOUBLE TAPERED FEMORAL STEM IN TOTAL HIP ARTHROPLASTY: A 5-YEAR RADIOSTEREOMETRIC ANALYSIS. STABLE FIXATION OF A CEMENTLESS, PROXIMALLY COATED, DOUBLE WEDGED, DOUBLE TAPERED FEMORAL STEM IN TOTAL HIP ARTHROPLASTY: A 5-YEAR RADIOSTEREOMETRIC ANALYSIS, 1267-1274. HTTP://DX.DOI.ORG/10.1016/J.ARTH.2015.11.036.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOUR PATIENTS EXPERIENCED SUBSIDENCE, MIGRATION AND RADIOLUCENCY WITHIN 5 YEARS POST PRIMARY SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOUR PTS EXPERIENCED SUBSIDENCE AND MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548547 UNKNOWN TAPERLOC FEMORAL STEM PROSTHESIS, HIP JDG BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1