BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPSILON DURASUL STANDARD INSERT

    MDR report key: 1963630 · Received December 21, 2010

    Report

    Report Number
    1822565-2010-01416
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: PT AGE, BUILD, WEIGHT, HEIGHT, AND ACTIVITY LEVEL ARE UNK. X-RAYS AND OPERATIVE NOTES WERE NOT PROVIDED. A BRIEF POST OPERATIVE NOTE WAS PROVIDED. IT INDICATES THAT A RIGHT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH NO COMPLICATIONS. THE IMPLANTS REMAIN IN-VIVO AND WERE IN SERVICE APPROX 3 YEARS SIX MONTHS AT THE TIME THE EXPERIENCE WAS REPORTED. SINCE THE IMPLANTS REMAIN IN-SITU, THEY WERE NOT RETURNED AND NO ANALYSIS WAS POSSIBLE. SINCE NO X-RAYS OR OPERATIVE REPORTS WERE PROVIDED, THE CONDITION OF THE IMPLANTS IS UNK. IT IS NOT KNOWN HOW THE DURASUL LINER WAS USED. GIVEN THE INFO PROVIDED, A DEFINITIVE CAUSE FOR THE EXPERIENCE OF PAIN AND SUBSEQUENTLY SCHEDULED REVISION SURGERY CANNOT BE DETERMINED WITH CERTAINTY. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN AND THAT REVISION SURGERY IS SCHEDULED FOR (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPSILON DURASUL STANDARD INSERT HIP PROSTHESIS JDI ZIMMER, INC. 60601861

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG # 735402101, LOT# 1485093| NATURAL-HIP SYSTEM TAPER POROUS STEM