BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS 3CM RESURFACING FEMORAL,RT

    MDR report key: 6907924 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07655
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    June 16, 2014
    Report Date
    September 29, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS IMPLANTED, AND THEREFORE IS NOT AVAILABLE FOR RETURN. INVESTIGATION RESULTS RELAYED TO THE SALES REP VIA EMAIL. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF DEVICE HISTORY RECORDS FOUND UNITS RELEASED FOR DISTRIBUTION WITH NO DEVIATION OR ANOMALY. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR THIS LOT. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL ISSUES REPORTED FOR ITEM: 150350 / LOT: 665580 COMBINATION. NO OTHER ISSUES REPORTED FOR ITEM: 150350 / COMPLAINT CATEGORY: PACKAGING : DAMAGED STERILE PACKAGING COMBINATION. INCONCLUSIVE-ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION PROCEDURE OF COMPETITOR PRODUCT ON (B)(6) 2014, THE RIGHT OSS DISTAL FEMUR PACKAGE WAS NOT SEALED. IT WAS ALSO REPORTED THAT A "BIOLOGIC INDICATOR" WAS USED AND THE IMPLANT WAS THEN IMPLANTED. THIS PROCEDURE CAUSE A 25 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687378 OSS 3CM RESURFACING FEMORAL,RT PROSTHESIS - KNEE JDI ZIMMER BIOMET, INC. N/A 665580

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR