BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2539071 · Received April 11, 2012

    Report

    Report Number
    1822565-2012-00768
    Event Type
    Injury
    Date Received
    April 11, 2012
    Report Date
    March 13, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS NOTED IN THE COMPLAINT THAT THE "PHYSICIAN IMPLANTED A RIGHT ZIMMER KNEE SYSTEM INCLUDING A LEFT NEXGEN LPS HIGH FLEX FEMORAL COMPONENT". COMBINING A RIGHT AND LEFT KNEE COMPONENT IS AN OFF-LABEL USE OF THE DEVICES. IT IS UNK HOW LONG THE DEVICES REMAINED IN-VIVO. IN GENERAL, OTHER PT 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. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. THE ROOT CAUSE OF THE EVENT DESCRIBED IS LIKELY THE OFF-LABEL USE OF THE LEFT AND RIGHT KNEE COMPONENTS TOGETHER. 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 REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention