BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G BONE CEMENT

    MDR report key: 1865216 · Received September 29, 2010

    Report

    Report Number
    1822565-2010-00832
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Report Date
    September 9, 2010
    Manufacturer
    HERAEUS MEDICAL GMBH
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BONE CEMENT IS MFG AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. EVAL SUMMARY: THE BATCH WAS FOUND TO BE WITHIN THE RANGE OF SPEC. HERAEUS REVIEWED THE BATCH IDENTIFIED WITHIN THE COMPLAINT AND FOUND IT TO BE WITHIN THE RANGE OF SPEC. THE MFG PROTOCOL WAS ALSO REVIEWED AND NO DISCREPANCIES COULD BE IDENTIFIED. THE EXACT CAUSE OF THE EVENT CANNOT BE DEFINITIVELY DETERMINED. EVAL: NO PRODUCT WAS RETURNED. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A REVISION SURGERY IS PENDING DUE TO THE BONE CEMENT NOT PROPERLY SECURING THE IMPLANT TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R+G BONE CEMENT BONE CEMENT LOD HERAEUS MEDICAL GMBH 66394166

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR