BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LINER

    MDR report key: 1830942 · Received September 7, 2010

    Report

    Report Number
    1822565-2010-00659
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 13, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO X-RAY, SURGICAL REPORT, MEDICAL HISTORY OF THE PATIENT, PATIENT ACTIVITY LEVEL AND WEIGHT HAS BEEN PROVIDED. IT IS UNKNOWN IF THE COMPONENTS WERE IMPLANTED ACCORDING TO THE SURGICAL TECHNIQUE. NO CAUSE ANALYSIS IS POSSIBLE AT THIS TIME BASED ON THE INFORMATION PROVIDED. 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 BY PATIENT'S COUNCIL THAT PATIENT UNDERWENT LEFT THA AND THAT PATIENT EXPERIENCED PAIN AND WAS REVISED (LINER AND HEAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM LINER HIP PROSTHESIS LPH ZIMMER, INC. 60185854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATALOG #00801802802, LOT# 60218209| VERSYS HIP SYSTEM FEMORAL HEAD| MANUFACTURED AT ZIMMER B.V., (B)(4)