BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM

    MDR report key: 4810467 · Received June 1, 2015

    Report

    Report Number
    2648920-2015-00189
    Event Type
    Injury
    Date Received
    June 1, 2015
    Report Date
    April 27, 2015
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THAT A SMITH AND NEPHEW BHR ACETABULAR CUP AND BIRMINGHAM MODULAR HEAD WAS USED WITH ZIMMER (B)(6) CPT COCR EXTENDED OFFSET STEM. THE SPECIFIC NON ZIMMER MODULAR COMPONENTS COULD NOT BE CONFIRMED BASED ON THE DESCRIPTION PROVIDED. 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. THE RECOMMENDED COMPATIBILITY CHART CAN BE FOUND AT WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM. REVIEW OF THE COMPLAINT HISTORY FOR LOT CODE ASSOCIATED WITH THE CPT STEM INDICATED NO PRIOR COMPLAINTS FOR THIS LOT. SURGICAL NOTES WERE NOT PROVIDED. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    INFORMATION RECENTLY RECIEVED DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT IS ALLEGING PERSONAL INJURIES ASSOCIATED WITH POSSIBLE FAILURE OF THE HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352858 CPT FEMORAL STEM LPH LPH ZIMMER MANUFACTURING B.V. 60491096

    Patients

    Seq Age Sex Outcome Treatment
    1 Other