BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN TIBIAL COMPONENT

    MDR report key: 6788995 · Received August 11, 2017

    Report

    Report Number
    0001822565-2017-05643
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    March 15, 2017
    Report Date
    August 11, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). GRO S. DYRHOVDEN (2017) "HAVE THE CAUSES OF REVISION FOR TOTAL AND UNICOMPARTMENTAL KNEE ARTHROPLASTIES CHANGED DURING THE PAST TWO DECADES?" CLINICAL ORTHOPAEDICS AND RELATED RESEARCH, 475:1874¿1886. CONCOMITANT DEVICES ¿ UNKNOWN NEXGEN FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN NEXGEN ARTICULAR SURFACE CATALOG #: NI LOT #: NI. THIS JOURNAL ARTICLE WAS WRITTEN BY GRO S. DYRHOVDEN, STEIN HAKON L. LYGRE, MONA BADAWY, OYSTEIN GOTHESEN AND OVE FURNES. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURNED CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A 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. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001822565-2017-05644).

    Description of Event or Problem · 1

    IT IS REPORTED IN A JOURNAL ARTICLE THAT FIFTY (50) PATIENTS UNDERWENT KNEE ARTHROPLASTY REVISIONS DUE TO PERIPROSTHETIC FRACTURES THAT OCCURRED POST-OPERATIVELY. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568089 UNKNOWN NEXGEN TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE