BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 3596434 · Received January 22, 2014

    Report

    Report Number
    1822565-2014-00103
    Event Type
    Injury
    Date Received
    January 22, 2014
    Report Date
    December 23, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS REPORTED THAT X-RAYS SHOW NO MOVEMENT OF THE COMPONENTS, AND ANALYSIS OF FLUID FROM AROUND THE HIP SHOWS NO INFECTION, HOWEVER NEITHER X-RAYS NOR LAB REPORTS HAVE BEEN RETURNED FOR REVIEW. OPERATIVE NOTES HAVE NOT BEEN RETURNED FOR REVIEW. THE COMPONENT FIT AND ORIENTATION PER THE SURGICAL TECHNIQUE IS UNK. 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. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. PRODUCT COMPATIBILITY IS UNK. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53276 UNKNOWN ZIMMER HIP HIP PROTHESIS LPH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other