BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LEGACY LPS ARTICULAR SURFACE

    MDR report key: 2078005 · Received April 21, 2011

    Report

    Report Number
    1822565-2011-01010
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE X-RAYS AND SURGICAL NOTES ARE NOT AVAILABLE TO ANALYZE THE FIXATION. THE PRODUCTS USED FOR IMPLANTATION ALONG WITH THE LPS ART SURFACE ARE UNK TO CHECK THE COMBINATION. THE COMPLAINT REPORT MENTIONS THAT POST EXPLANATION, SURGEON OBSERVED FRACTURED SPINE OF THE ART SURFACE. THE FRACTURED SPINE COULD BE A CAUSE FOR THE PT'S INSTABILITY. HOWEVER, THE REASON FOR SPINE FRACTURE IS UNK. SPINE FRACTURE COULD OCCUR DUE TO IMPROPER/HIGH LOADS PARTICULARLY WITH EXTERNAL/INTERNAL ROTATION OF THE KNEE. THE FRACTURE IN THE ART SURFACE COULD ALSO BE DUE TO PT'S INJURY/NON-COMPLIANCE BUT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT PRESENTED WITH AN UNSTABLE KNEE. AFTER REVIEW OF THE FEMORAL AND TIBIAL COMPONENTS, THE SURGEON DECIDED TO ONLY EXCHANGE THE ARTICULAR SURFACE. UPON REMOVAL, IT WAS DETERMINED THAT THE PROBABLE CAUSE OF INSTABILITY WAS DUE TO THE SPINE OF THE ARTICULAR SURFACE HAVING FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LEGACY LPS ARTICULAR SURFACE JWH ZIMMER, INC. 68455200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention