BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPX-FLEX GSF FEMORAL COMPONENT

    MDR report key: 2251501 · Received September 14, 2011

    Report

    Report Number
    3007963827-2011-00002
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    March 22, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. NO X-RAYS WERE RECEIVED, SO THE ORIGINAL FIT AND ORIENTATION COULD NOT BE EVALUATED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, (B)(4) CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR A PERIPROSTHETIC FEMUR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPX-FLEX GSF FEMORAL COMPONENT JWH ZIMMER 61661618

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention