BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER HIP

    MDR report key: 4092096 · Received August 21, 2014

    Report

    Report Number
    1822565-2014-01021
    Event Type
    Injury
    Date Received
    August 21, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES WERE PROVIDED AND WERE UNREMARKABLE. X-RAYS FROM AN UNK DATE WERE PROVIDED WHICH SHOW THAT THE FEMORAL HEAD IS NOT CONCENTRIC WITHIN THE ACETABULAR SHELL. IT APPEARS TO BE SHIFTED SUPERIORLY WHICH MAY INDICATE SUBLUXATION OR A FRACTURED LINER, HOWEVER THIS CANNOT BE CONFIRMED. THE VERSION OF THE SHELL ALSO APPEARS TO BE POTENTIALLY HIGHER THAN THE RECOMMENDED 20 DEGREES. IN GENERAL PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AG, 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. WITH THE INFO PROVIDED, IT IS LIKELY THAT THE SHIFT IN THE FEMORAL HEAD IS SECONDARY TO ANTHER ISSUE CAUSING THE PT'S PAIN; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBER 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.

    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
    504505 UNK ZIMMER HIP HIP PROSTHESIS JDI ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other