BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP STEM

    MDR report key: 2191021 · Received July 29, 2011

    Report

    Report Number
    1822565-2011-01741
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    August 13, 2010
    Report Date
    July 1, 2011
    Manufacturer
    ZIMMER INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ON AN X-RAY OF THE PT'S RIGHT FEMUR THAT WAS PROVIDED FOR REVIEW, IT APPEARS THAT THERE IS A PERIPROSTHETIC FRACTURE OF THE FEMUR; HOWEVER, THE STEM DOES NOT LOOK AFFECTED. THE FRACTURE OCCURRED HALFWAY DOWN THE IMPLANT. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. IN GENERAL, PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT), RELEVANT MEDICAL HISTORY, AND ADHERENCE TO REHABILITATION PROTOCOL. A LETTER DATED (B)(4), 2011 STATES THAT THE FRACTURE WAS CAUSED BY WEAKENING OF THE FEMUR PRIOR TO REVISION. IT IS UNK IF THE STEM CAUSED THE FEMUR TO WEAKEN. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED FRACTURE OF RIGHT FEMUR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other