BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL MODULAR SHELL

    MDR report key: 2030656 · Received March 18, 2011

    Report

    Report Number
    1822565-2011-00652
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    May 12, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE STERILIZATION PROCESS FOR THESE DEVICES WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10(-6) OR BETTER. THE LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE DEVICES CAUSED OR CONTRIBUTED TO ANY INFECTION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL MODULAR SHELL JDI ZIMMER, INC. 60495509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BONE SCREW, CATALOG #00625006520, LOT #60527329| CATALOG #00642803203, LOT #60482747| VERSYS FEMORAL STEM, CATALOG #00784301206| LOT #60404808| ALUMINA CERAMIC FEMORAL HEAD,| CATALOG #00631004832, LOT#60398070| TRILOGY LONGEVITY CROSSLINKED POLYETHYLENE LINER