BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM ELEVATED RIM LINER

    MDR report key: 1241112 · Received November 21, 2008

    Report

    Report Number
    1822565-2008-00818
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY - THE ALLEGED COMPLIANT REFERS TO A POLY LINER THAT SHOWED SIGNS OF CRACKING/WEAR SO MUCH THAT THERE WAS A "LOOSE" PORTION OF THE LINER THAT WAS PHYSICALLY MOVING. THE DEVICE AND/OR X-RAYS WERE NOT RETURNED FOR REVIEW. IT IS PROBABLE THAT THE LINER'S ALLEGED WEAR AND CRACKING WAS DUE TO THE IMPACT OF THE PATIENT'S REPETITIVE DISLOCATIONS AND ULTIMATE FALL (AGAIN CAUSING DISLOCATION). THE PATIENT WAS REVISED AFTER APPROXIMATELY 10 YEARS. PATIENT INFORMATION SUCH AS WEIGHT AND ACTIVITY LEVEL WERE NOT SUPPLIED. THE OTHER COMPONENTS THAT THE LINER WAS MATED WITH WERE NOT NOTED. THE CAUSE CAN NOT BE DETERMINED WITH CERTAINTY. 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 THE DEVICE WAS IMPLANTED IN 1999 AND REVISED IN 2008, DUE TO THE LAST SEVERAL MONTHS THE PATIENT REPORTED TWO DISLOCATIONS OF AFFECTED HIP BUT DID NOT GO AND SEE THE SURGEON WHO PERFORMED THE PRIMARY HIP REPLACEMENT PROCEDURE. THEN AS RECENTLY AS TWO WEEKS AGO THE PATIENT FELL AND ONCE AGAIN DISLOCATED THE AFFECTED HIP. AT THIS POINT THE PATIENT CONTACTED DR. WHO WAS THE SURGEON THAT PERFORMED THE PRIMARY HIP REPLACEMENT AS WELL AS THIS REVISION. DURING THE REVISION, DR. NOTED THAT THE POLY LINER HAD SIGNS OF CRACKING/WEAR SO MUCH SO THAT THERE WAS A "LOOSE" PORTION OF THE LINER THAT WAS PHYSICALLY MOVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM ELEVATED RIM LINER HIP PROSTHESIS KWB ZIMMER, INC. NA 59907600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R