BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN OSS ORTHOPAEDIC SALVAGE SYSTEM

    MDR report key: 6968043 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09519
    Event Type
    Death
    Date Received
    October 23, 2017
    Report Date
    October 24, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FARID, Y. R., THAKRAL, R., & FINN, H. A. (2015). INTERMEDIATE-TERM RESULTS OF 142 SINGLE-DESIGN, ROTATING-HINGE IMPLANTS: FREQUENT COMPLICATIONS MAY NOT PRECLUDE SALVAGE OF SEVERELY AFFECTED KNEES. THE JOURNAL OF ARTHROPLASTY, 30(12), 2173-2180. DOI:10.1016/J.ARTH.2015.06.033. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY, NEITHER WERE PROVIDED. RISKS ASSOCIATED WITH REPORTED CONDITION ARE ADDRESSED THROUGH THE WARNINGS IN THE PACKAGE INSERT AS A PART OF DESIGN CONTROL RISK MANAGEMENT. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO RELAY THAT THIS IS A CORRECTION TO REPORT A DUPLICATE OF MDR REPORT 1825034-2015-04261.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "INTERMEDIATE-TERM RESULTS OF (B)(4) SINGLE-DESIGN, ROTATING-HINGE IMPLANTS: FREQUENT COMPLICATIONS MAY NOT PRECLUDE SALVAGE OF SEVERELY AFFECTED KNEES". THE (B)(6) PATIENTS WERE IDENTIFIED IN THE ARTICLE WHO WERE DECEASED FOR UNKNOWN REASON ON AN UNKNOWN DATE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED . ALL OTHER EVENTS WILL BE REPORTED IN INDIVIDUAL RECORDS WHICH WILL BE LINKED TO PARENT RECORD.

    Description of Event or Problem · 1

    THIRTY-FIVE (35) PATIENTS WERE DECEASED FOR UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749592 UNKNOWN OSS ORTHOPAEDIC SALVAGE SYSTEM PROSTHESIS - UNKNOWN JDI ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death