BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ACETABULAR CEMENTED POLYETHYLENE LINER

    MDR report key: 2100555 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01188
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE LINER AND CORRESPONDING IMPLANTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE LINER WAS REPORTED TO HAVE BEEN IN VIVO FOR APPROX (B)(6). THERE IS INSUFFICIENT INFO TO PERFORM A PROBABLE CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: THE LINER WAS NOT RETURNED FOR REVIEW. THE MFG RECORDS OF THE LINER WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICES WERE MFG, INSPECTED, AND PACKAGED TO SPEC. 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 ADD'L 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 THE PT WAS REVISED DUE THE LINER DISASSOCIATING FROM THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM ACETABULAR CEMENTED POLYETHYLENE LINER KWZ ZIMMER, INC. 61562112

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention