BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 2023287 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00579
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 26, 2008
    Report Date
    September 23, 2009
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CONDITION IS UNK. IT IS NOT KNOWN IF THE STEM WAS IMPLANTED WITH THE CORRECT ORIENTATION AND FIT AS PER THE SURGICAL TECHNIQUE. X-RAYS ARE UNAVAILABLE. INSTRUMENTS USED AS WELL AS PT HEIGHT, WEIGHT, AND ACTIVITY LEVEL ARE UNK. REHABILITATION PROGRAM, BOTH PHYSICAL AND PHARMACOLOGICAL, AND COMPLIANCE THEREOF IS UNK. THE PROBABLE CAUSE FOR LOOSENING IS UNK. THE STERILIZATION PROCESS FOR THIS DEVICE WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10 (-6) OR BETTER. THIS LOT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. IN ADDITION, BEFORE EACH LOT IS RELEASED, THE "CERTIFICATE OF PROCESSING" FROM THE STERILIZATION SUPPLIER IS REVIEWED FOR CONFORMANCE. THIS CERTIFICATE LISTS THE MAXIMUM, MINIMUM AND ACTUAL GAMMA DOSE IN KGY. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE DEVICE CAUSED OR CONTRIBUTED TO INFECTION. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 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 PT EXPERIENCED PAIN AND THE DEVICE WAS FOUND TO BE LOOSE. THE PT ALSO HAD A POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER FEMORAL STEM MEH ZIMMER, INC. 60425913

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention