BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUMED CALLOS IMPACT 5CC AND 10CC

    MDR report key: 1557136 · Received November 25, 2009

    Report

    Report Number
    3003890476-2009-00007
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    April 6, 2009
    Report Date
    November 25, 2009
    Manufacturer
    SKELETAL KINETICS, LLC
    Product Code
    MQV
    PMA / PMN Number
    K051123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG #: 65-0110-S. ADDITIONAL LOT #S: 08071104, 08070207, 08101304. ADDITIONAL EXPIRATION DATE: 07/22/2009. ADDITIONAL OTHER: 10/27/2009. ADD'L MANUFACURE DATES: 08/2008, 09/2008, 11/2008. CATALOG # 65-0105-S, LOT #S 08090506, 08070207, 08101304 AND CATALOG #65-0110-S, LOT #08071104 MET ALL FUNCTIONAL AND STERILIZATION CRITERIA UPON RELEASE PER BATCH RECORD REVIEW. ON GOING STABILITY TESTING PERFORMED OF THE ALLEGED LOTS WAS ALSO WITHIN SPECIFICATION (SETTING, TENSILE STRENGTH, MIXING ETC.)

    Description of Event or Problem · 1

    DURING A CASE OF DEBRIDEMENT AVASCULAR NECROSIS (AVN) RIGHT HEAD OF FEMUR, ACUMED CALLOS IMPACT 5CC AND 10CC WERE MIXED, THEY NEVER TURNED TO A PASTE BUT JUST FELL TO BITS IMMEDIATELY (LESS THAN 1 MINUTE); THE SAME PROBLEM OCCURRED (BRITTLE AND BITS BEFORE 1 MINUTE MIXING TIME UP) FOR ANOTHER BATCH (2X5CC); THE LAST BATCH (2X5CC) WERE MIXED, THIS TIME A PASTE BEGAN TO FORM BUT DRIED OUT TO A CHALK LIKE BRITTLE SUBSTANCE BEFORE THE 2 MINUTE IMPACTABLE TIME IN THE PRE-OPERATIVE PLANNING WAS UP, MAKING IT IMPOSSIBLE TO IMPLANT INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMED CALLOS IMPACT 5CC AND 10CC 21 CFR 888.3045 MQV MQV SKELETAL KINETICS, LLC 08090506

    Patients

    Seq Age Sex Outcome Treatment
    1