BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM

    MDR report key: 4817785 · Received June 2, 2015

    Report

    Report Number
    2648920-2015-00193
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    April 29, 2015
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. IT IS REPORTED THAT THE FINSBURY ADEPT, ACETABULAR CUP AND MODULAR HEAD WERE USED WITH ZIMMER CPT 12/14 SIZE 1 COCR EXT FEMORAL STEM. ZIMMER HAS NOT TESTED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. WITH THE INFORMATION PROVIDED IT IS UNKNOWN IF THE PRODUCT INCOMPATIBILITY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT; HOWEVER, CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE DEVICES REMAIN IMPLANTED. 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 THAT THE PATIENT RECEIVED A MIX MATCH WITH IMPLANTS CONSISTING OF A FINSBURY ACETABULAR CUP, MODULAR HEAD, AND ZIMMER FEMORAL STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356703 CPT FEMORAL STEM JDI ZIMMER 60261825

    Patients

    Seq Age Sex Outcome Treatment
    1