BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 4162827 · Received October 8, 2014

    Report

    Report Number
    1822565-2014-01308
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: NEITHER OPERATIVE NOTES NOR X-RAYS ARE AVAILABLE FOR REVIEW. THE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNKNOWN. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THA 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REPORTED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT IS EXPERIENCING PAIN AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631559 UNKNOWN ZIMMER HIP HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1