BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT HIP SYSTEM FEMORAL STEM

    MDR report key: 2082882 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01069
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    June 19, 2008
    Report Date
    April 7, 2011
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: SINCE NO DEVICES OR PHOTOS WERE AVAILABLE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE PROVIDED FROM THE PRIMARY SURGERY. BONE QUALITY WAS DESCRIBED AS EXCELLENT. THE PATIENT WAS DESCRIBED AS HAVING AN EXTREMELY VARUS HIP REQUIRING DEEP IMPLANTATION OF THE PROTHESIS. IT WAS STATED THAT THE FEMORAL BROACH FOR THE SIZE 0 CEMENTED CPT PROSTHESIS WAS ADVANCED TO THE TEMPLATED LEVEL AND BECAUSE OF THE SMALL SIZE OF THE FEMUR AND TIGHT CANAL, A TROCHANTERIC FRACTURE WAS PROPAGATED. NO OTHER DETAILS REGARDING THE METHOD OF BROACHING WERE PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PROXIMAL FEMUR FRACTURE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 THAT THE PROXIMAL FEMUR FRACTURED DURING TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CPT HIP SYSTEM FEMORAL STEM JDI ZIMMER 60660094

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other MFG AT ZIMMER INC., (B)(4)| LOT #60173786| CPT HIP SYSTEM CENTRALIZER: CATALOG #32833305500,