BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ULNAR COMPONENT

    MDR report key: 7289056 · Received February 22, 2018

    Report

    Report Number
    0001822565-2018-01093
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    July 18, 2017
    Report Date
    February 22, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, UNKNOWN HUMERAL COMPONENT, UNKNOWN. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(4). REPORT SOURCE, LITERATURE: LAMI, D., CHIVOT, M., CAUBERE, A., GALLAND, A., ARGENSON, J.N. (2017). FIRST-LINE MANAGEMENT OF DISTAL HUMERUS FRACTURE BY TOTAL ELBOW ARTHROPLASTY IN GERIATRIC TRAUMATOLOGY: RESULTS IN A 21-PATIENT SERIES AT A MINIMUM 2 YEARS¿ FOLLOW-UP. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH, 103(6), 891-897. DOI: 10.1016/J.OTSR.2017.06.009. 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. 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: 0001822565-2018-01092. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FOUR PATIENTS DEVELOPED PERIPROSTHETIC OSSIFICATION WITHOUT PAIN OR FUNCTIONAL IMPACT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134562 UNKNOWN ULNAR COMPONENT PROSTHESIS, ELBOW JDC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other