BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD III KNEE

    MDR report key: 7002574 · Received November 6, 2017

    Report

    Report Number
    0001825034-2017-09940
    Event Type
    Injury
    Date Received
    November 6, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (B)(4). THE PRODUCT WAS NOT RETURNED FOR EVALUATION DUE TO UNKNOWN LOCATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) AND COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT/ITEM 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. LITERATURE: PIETSCHMANN, M.F, WOHLEB, L, WEBER, P, SCHMIDUTZ, F, FICKLSCHERER, A, GULECYUZ, M. F, SALI, E, NIETHAMMER, T. R, JANSSON, V, & MULLER, P.E (2013) SPORTS ACTIVITIES AFTER MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY OXFORD III- WHAT CAN WE EXPECT? INTERNATIONAL ORTHOPAEDICS (SICOT) (2013) 37:31¿37. DOI 10.1007/S00264-012-1710-7 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 BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. ZIMMER BIOMET COMPLAINT (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF JOURNAL ARTICLE TITLED, "SPORTS ACTIVITIES AFTER MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY OXFORD III- WHAT CAN WE EXPECT?" A REVIEW OF THE ARTICLE IDENTIFIED FIVE (5) PATIENTS THAT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN SIDE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENTS WERE REVISED ON AN UNKNOWN DATE DUE TO DISEASE PROGRESSION OF OSTEOARTHRITIS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED AND THE PATIENTS OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783356 UNKNOWN OXFORD III KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R