BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR LINER

    MDR report key: 1822704 · Received August 26, 2010

    Report

    Report Number
    1822565-2010-00622
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICE USED: CATALOG #00801803602, VERSYS FEMORAL HEAD, LOT #61112101 MANUFACTURED BY ZIMMER B.V. (B)(4). EVALUATION SUMMARY: FACTORS WHICH MAY CONTRIBUTE TO DISLOCATION MAY BE ONE OR A COMBINATION OF THE FOLLOWING MECHANISMS: IMPROPER PLACEMENT OF THE COMPONENT PARTS, IMPROPER NECK LENGTH AND OFFSET, MALALIGNMENT OF THE FEMORAL STEM/NECK ASSEMBLY, MISALIGNMENT OF ACETABULAR CUP, EXTENT OF MISSING CONNECTIVITY BETWEEN THE STEM/NECK/HEAD INTERFACES, EXTENT OF SOFT TISSUE TENSION, IMPINGEMENT, EXTENT OF REDUCTION DURING SURGERY, OR PATIENT'S HEALTH, MUSCLE LAXITY, MEDICAL HISTORY, AND ACTIVITY LEVEL. WITHOUT MORE INFORMATION, THE EXACT CAUSE FOR THIS EVENT CANNOT BE DETERMINED, HOWEVER IT IS DEEMED HIGHLY UNLIKELY THAT THE DEVICE IN QUESTION CONTRIBUTED DIRECTLY TO THE COMPLICATIONS DESCRIBED. ALTERNATIVELY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. 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 RE-OPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT WAS REVISED DUE TO SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR LINER HIP IMPLANT KWB ZIMMER, INC. 60970571

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR