BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 4092245 · Received August 20, 2014

    Report

    Report Number
    1822565-2014-00991
    Event Type
    Injury
    Date Received
    August 20, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE DEVICES HAVE AN IN-VIVO TIME OF NEARLY 4 AND A HALF YEARS TO DATE. A SECOND OPINION HAS TOLD THE PATIENT THAT THE PAIN MAY BE CAUSED BY THE IMPLANT NOT BEING INGROWN, HOWEVER X-RAYS HAVE NOT BEEN PROVIDED FOR ASSESSMENT. SURGICAL NOTES HAVE NOT BEEN PROVIDED. THE COMPONENT FIT AND ORIENTATION ARE UNKNOWN. PRODUCT COMPATIBILITY IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY, ARE UNKNOWN. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, AND THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERED THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING SEVERE PAIN IN THE THIGH, BONE, AND HIP. IT IS ALSO REPORTED THE STEM IS SHIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500688 UNKNOWN ZIMMER HIP HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other