BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER M/L TAPER FEMORAL STEM

    MDR report key: 1830937 · Received September 7, 2010

    Report

    Report Number
    1822565-2010-00662
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    February 2, 2009
    Report Date
    August 10, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE EXPLANTS WERE NOT RETURNED FOR REVIEW. 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. THE MANUFACTURING LOT SPECIFIED IN THIS COMPLAINT WAS PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. IN ADDITION, BEFORE EACH MANUFACTURING 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. REQUIRED MINIMUM DOSE IS 25.0 KGY. ACTUAL MINIMUM DOSE WAS 26.1 KGY. REQUIRED MAXIMUM DOSE IS 37.0 KGY. ACTUAL MAXIMUM DOSE WAS 34.6 KGY. IT IS HIGHLY UNLIKELY, THEREFORE, THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. ACTUAL CAUSE OF INFECTION IS UNKNOWN. 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 THE PATIENT'S COUNSEL THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. TI IS ALSO REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED HIP IMPLANT AND OSTEOMYELITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER FEMORAL STEM HIP PROSTHESIS JDI ZIMMER, INC. 60128527

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention