BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIPOLAR BIPOLAR CUP SHELL

    MDR report key: 1162267 · Received September 5, 2008

    Report

    Report Number
    2648920-2008-00050
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ZIMMER, MFG. B.V.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HAIR LIKE SUBSTANCE OR PACKAGING MATERIAL WAS NOT RETURNED FOR EVALUATION. AS SUCH, IT CANNOT BE DEMONSTRATED WITH CERTAINTY THAT THE SOURCE OF THE HAIR IS THE PACKAGING ENVIRONMENT. DEVICE HISTORY RECORDS ARE IN ORDER AND DO NOT INDICATE ANY PACKAGING ANOMALIES. THE PACKAGING ENVIRONMENT UTILIZED FOR THIS PRODUCT IS A CLASS CLEAN ROOM THAT UNDERGOES CONTINUOUS MONITORING. THERE IS A VERY MINUSCULE, BUT CONSTANT RISK OF FOREIGN MATERIAL IN STERILE CAVITIES FROM THE OPERATORS. A REVIEW OF COMPLAINT STERILE UNITS SHIPPED BY ZIMMER IN THE PAST 5 YEARS. NO FURTHER ACTION OR EVALUATION IS INDICATED FOR THIS COMPLAINT. TRENDS CONTINUE TO BE MONITORED. THE COMPLAINT LOT WAS FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THIS KIND. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY IN 2008, A HAIR WAS FOUND INSIDE THE STERILE PACKAGING BEFORE IMPLANT WAS OPENED. THE HAIR DID NOT COME IN CONTACT WITH THE IMPLANT AND IT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIPOLAR BIPOLAR CUP SHELL HIP PROSTHESIS KWB ZIMMER, MFG. B.V. NA 60907234

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR