BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS LV 1X40 SINGLE BONE CEMENT

    MDR report key: 1163632 · Received September 9, 2008

    Report

    Report Number
    1822565-2008-00589
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT STATED THAT THE CEMENT HARDENED TOO SLOWLY. CAREFUL EXAMINATION OF THE BATCH MANUFACTURING RECORD DID NOT REVEAL ANY DISCREPANCIES OR IRREGULARITIES. A RETAIN SAMPLE AND A RETURNED SAMPLE RETURNED FROM THE CUSTOMER WERE CHECKED FOR THEIR HANDLING PROPERTIES. NO DEVIATIONS WERE FOUND, AND BOTH SAMPLES WERE ACCORDING TO THE SPECIFICATION IN ALL TESTED POINTS. WE THEREFORE, CONSIDER THIS CASE CLOSED. IF FURTHER INFORMATION BECOMES AVAILABLE, WE WILL REOPEN IT. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A HEMI-ARTHROPLASTY, 3 DOSES OF PALACOS LV WERE MIXED ON THE BACK TABLE BY THE SURGICAL TECH WITH A BIOMET MIXING SYSTEM. AFTER MIXING CONSISTENCY APPEARED NORMAL, SET TIME TOOK APPROXIMATELY 25-30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS LV 1X40 SINGLE BONE CEMENT BONE CEMENT LOD ZIMMER, INC. NA 65014019

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR