BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR STANDARD LINER

    MDR report key: 2031369 · Received March 23, 2011

    Report

    Report Number
    1822565-2011-00718
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: SURGICAL NOTES OF BOTH THE PRIMARY AND REVISION SURGERIES WERE REVIEWED, BUT DID NOT EXHIBIT ANY COMPLICATIONS. THE REVISION OP NOTES INDICATED THAT THE SURGEON REMOVED SOME OSTEOLYTIC DEBRIS FROM THE JOINT SITE. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE ACTIVITY OF THE PT IS UNK. THE IMPLANTS WERE IN VIVO FOR 11.5 YEARS, SO IT IS REASONABLE TO ASSUME THAT THE DEVICE WILL EXHIBIT WEAR AS IT IS LOADED THROUGHOUT THE LIFETIME OF THE DEVICE. WITHOUT THE RETURN OF THE IMPLANTED DEVICES, X-RAYS, OR OTHER SUPPORTING INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION: THE MANUFACTURING RECORDS OF THE DEVICES IMPLANTED WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THEY WERE MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. 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 THE PT WAS REVISED DUE TO WEAR OF THE POLYETHYLENE LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR STANDARD LINER LPH ZIMMER INC 60951200

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention