BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 2051505 · Received April 7, 2011

    Report

    Report Number
    1822565-2011-00876
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    June 9, 1999
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DISCHARGE SUMMARY SUMMARIZES THE SEQUENCE OF EVENTS THAT COULD HAVE CAUSED THE PT'S HIP TO BECOME UNSTABLE. THE IMPLANT WAS PLACED IN THE PT PROUD DUE TO THE EXTREMELY TIGHT FIT ((B)(6) 1998). THE SURGEON RECOMMENDED THAT LIMITED WEIGHT BEARING BE PLACED ON THE JOINT THROUGH 90 DAYS HOWEVER THE PT PROCEEDED WITH RAPIDLY INCREASED WEIGHT BEARING, IT WAS NOTED THAT THE FEMORAL COMPONENT HAD SUBSIDED SIGNIFICANTLY. IT IS NOT KNOWN AT THIS TIME IF ALL OF THE PRODUCTS IMPLANTED WERE ZIMMER PRODUCTS. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. THERE IS INSUFFICIENT INFO TO DETERMINE WHETHER ADDITIONAL FACTORS OUTSIDE OF THE IMPLANT SUBSIDENCE CAUSED THE JOINT INSTABILITY. EVALUATION: 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. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO INSTABILITY. THE HEAD AND LINER WERE REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention