BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERGE ACETABULAR SYSTEM HEMISPHERICAL POROUS SHELL WITH SEALED SCREWHOLES

    MDR report key: 1234730 · Received November 5, 2008

    Report

    Report Number
    1822565-2008-00762
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: A REVIEW OF THE MANUFACTURING RECORDS INDICATE THAT THE PLUGS WERE ISSUED TO THE ORDER AND WERE PACKAGED ACCORDING TO SPECIFICATION. A STOCK INVESTIGATION OF TWO REMAINING UNITS FROM ONE OF THE REPORTED LOTS WAS FOUND TO BE CONFORMING AND THE REMAINING UNITS FROM THE REPORTED LOTS WERE FULLY DISTRIBUTED WITHOUT ANY FURTHER REPORTS OF THE KIND. IT CAN NOT BE DETERMINED WITH CERTAINTY THE CAUSE OF THE REPORT, BUT IT IS POSSIBLE THAT THE PLUGS MAY HAVE BEEN DISCARDED AFTER BEING DISTRIBUTED DUE TO THEIR LIGHT WEIGHT AND SMALL SIZE. 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THERE WERE NO DOME PLUGS IN BOTH OF THE IMPLANTS MENTIONED. WE HAD TO OPEN ANOTHER BOX TO HAVE A DOME SEAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVERGE ACETABULAR SYSTEM HEMISPHERICAL POROUS SHELL WITH SEALED SCREWHOLES HIP PROSTHESIS KWB ZIMMER, INC. NA 60910059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SHELL WITH SEALED SCREWHOLES| CATALOG#: 636000053| CONVERGE ACETABULAR SYSTEM HEMISPHERICAL POROUS