BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER PERIARTICULAR LOCKING TIBIAL PLATE

    MDR report key: 1841599 · Received September 16, 2010

    Report

    Report Number
    1822565-2010-00708
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    February 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: IT IS INDICATED THAT THE PT WAS NON COMPLIANT WHICH COULD HAVE BEEN THE REASON FOR FRACTURE, BUT CANNOT BE CONFIRMED WITH THE AVAILABLE INFO. THE SURGICAL TECHNIQUE USED IS UNK, NO POST OP X-RAYS WERE PROVIDED, PT'S HEIGHT, WEIGHT AND BONE QUALITY ARE UNK. THERE IS INSUFFICIENT INFO PROVIDED TO DETERMINE THE ROOT CAUSE OF THE EVENT. MFG RECORDS ARE IN ORDER AND DO NOT INDICATE ANY MFG ANOMALIES. SEM ANALYSIS RESULTS INDICATE THAT THE FRACTURE OCCURRED BY FATIGUE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE LOCKING PLATE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER PERIARTICULAR LOCKING TIBIAL PLATE TRAUMA PROSTHESIS HRS ZIMMER, INC. 60486142

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention