BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERAL STRAIGHT STEM 15.0 12/14

    MDR report key: 2512418 · Received March 28, 2012

    Report

    Report Number
    9613350-2012-00363
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 29, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE IS REPORTED AS THE PRODUCT IS SIMILAR TO THE MULLER STRAIGHT STEM FEMORAL PROSTHESIS (510 K NUMBER K923808) ALTHOUGH THERE IS A DIFFERENT ARTICLE NUMBER OUTSIDE THE US. THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. 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 TO THE POWER OF -6 OR BETTER. THE MFG 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 SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION OF THE PT. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE STEM WAS REVISED BECAUSE THERE WAS A PERIPROSTHETIC INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LATERAL STRAIGHT STEM 15.0 12/14 NONE KWB ZIMMER GMBH 2586198

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R