BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2950009 · Received February 6, 2013

    Report

    Report Number
    1822565-2013-00251
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    April 11, 2011
    Report Date
    January 7, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: REVIEW OF SURGICAL REPORT PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. X-RAYS WERE RECEIVED. REVIEW OF THE MEDICAL HISTORY REPORT FOR THE ARTHROSCOPIC PROCEDURE INDICATED THAT THE PT HAD FALLEN A FEW TIMES ON THE ICE. THESE FALLS COULD BE THE CAUSE OF THE REPORTED PAIN, SWELLING AND BLEEDING THAT LED TO THE ARTHROSCOPIC SURGERY AND THE DEBRIS DETECTED THEREIN. EVAL: 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 INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN ASPIRATION ON AN UNK DATE, AS WELL AS AN ARTHROSCOPIC KNEE PROCEDURE DUE TO PAIN, SWELLING, AND BLEEDING INTO THE KNEE JOINT. DURING ARTHROSCOPY, DEBRIS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51467 NEXGEN LPS-FLEX FEMORAL COMPONENT NJL ZIMMER, INC. 61328523

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ZIMMER (B)(4).| CATALOG# 00598801215, LOT# 61456552| LOT# 61424470| NEXGEN STRAIGHT STEM EXTENSION:| LOT# 61407366| NEXGEN ALL POLY PATELLA: CATALOG# 00597206541,| CATALOG# 00596205012, LOT# 61414088| NEXGEN PROLONG LPS-FLEX ARTICULAR SURFACE:| THE FOLLOWING COMPONENTS WERE MANUFACTURED AT| NEXGEN FLUTED TIBIAL STEM: CATALOG# 00599605801,