BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 2023292 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00592
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2010
    Report Date
    February 23, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IT APPEARS THAT THE PT HAD A TRAUMA INJURY AND WAS REVISED DUE TO PAIN. HOWEVER, IT IS NOT CLEAR WHETHER THE PT WAS INJURED DUE TO FALL OR OTHER TYPE OF INJURY. PRE-OP AND POST-OP X-RAYS ARE UNAVAILABLE TO STUDY THE IMPLANTATION AND AFTER EFFECTS OF INJURY. THERE IS ALSO INSUFFICIENT INFO ON HOW THE REVISION WAS PERFORMED. THE RETURNED PARTS WERE ANALYZED THROUGH SEM AND STEM FRACTURE SURFACED FATIGUE STRIATIONS INDICATING FATIGUE FRACTURE OVER A PERIOD OF 10 YRS. HOWEVER, WITH THE EXISTING INFO, A DEFINITIVE ROOT CAUSE CANNOT BE ATTRIBUTED TO THE ALLEGED COMPLAINT. EVALUATION: 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. THIS MDR WAS IDENTIFIED DURING AN INTERNAL REVIEW TO MEET REPORTING REQUIREMENTS AND THEREFORE IS BEING FILED LATE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED FOR A MEDIAL PLATEAU FRACTURE AND PAIN FROM TRAUMA INJURY. DURING THE REVISION IT WAS FOUND THAT THE STEM EXTENSION WAS FRACTURED AND IT REQUIRED TWO HRS TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER, INC. 60193211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION,| CAT# 00598802112, LOT# 41991000