BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 6928120 · Received October 9, 2017

    Report

    Report Number
    0001825034-2017-08141
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    October 6, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    NRA
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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) 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION: UNDER POSSIBLE ADVERSE EFFECTS NUMBER 4: ¿LOOSENING, MIGRATION, OR FRACTURE OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, MALPOSITION, NON-UNION, BONE RESORPTION AND/OR EXCESSIVE UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY.¿ FOLLOWING REVIEW, NO NEW RISKS WERE IDENTIFIED. 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. EMERSON JR, R. H., & HIGGINS, L. L. (2008). UNICOMPARTMENTAL KNEE ARTHROPLASTY WITH THE OXFORD PROSTHESIS IN PATIENTS WITH MEDIAL COMPARTMENT ARTHRITIS. THE JOURNAL OF BONE AND JOINT SURGERY INCORPORATED, 90-A, 118-122.¿ ZIMMER BIOMET COMPLAINT NUMBER: CMP-(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034¿2017¿08120 / 08125 / 08144 / 08145. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "UNICOMPARTMENTAL KNEE ARTHROPLASTY WITH THE OXFORD PROSTHESIS IN PATIENTS WITH MEDIAL COMPARTMENT ARTHRITIS." THE ARTICLE NOTED MULTIPLE EVENTS OF RADIOLUCENT LINES IDENTIFIED ON UNKNOWN DATES. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENTS OUTCOMES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711596 UNKNOWN KNEE PROSTHESIS, KNEE NRA ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention