BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX ARTICULAR SURFACE

    MDR report key: 2950040 · Received February 6, 2013

    Report

    Report Number
    1822565-2013-00252
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    June 26, 2012
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL REPORTS PROVIDED WERE REVIEWED. THE DEBRIDEMENT SURGICAL REPORT STATES THAT THE DEBRIDEMENT INCLUDED TWO EXCRETIONS OF ABOUT 2-3 MM OF EXTRUDED CEMENT. THE LAST FOLLOW UP REPORT PROVIDED STATED THAT DEBRIDING THE LATERAL CONDYLAR AREA AND REMOVING THE CEMENT EXTRUSION HAS HELPED THE PT DRAMATICALLY. NO X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE STATEMENTS MADE IN THE SURGICAL REPORTS INDICATE THAT THE DEBRIDEMENT SURGERY WAS AT LEAST PARTIALLY DUE TO SURGICAL TECHNIQUE, WHEREBY EXCESS BONE CEMENT HAD NOT BEEN REMOVED IN ACCORDANCE WITH SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT EXPERIENCED PAIN. THE PT UNDERWENT DEBRIDEMENT OF CEMENT, DEBRIDEMENT OF SYNOVIUM AND RELEASE OF THE ILIOTIBIAL BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51111 NEXGEN LPS-FLEX ARTICULAR SURFACE JWH ZIMMER, INC. 60304676

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention LOT# 60959656| CATALOG# 00599401791, LOT# 60948648| NEXGEN WEDGED TIBIAL PLATE: CATALOG# 00598800600,| NEXGEN LCCK FEMORAL COMPONENT: