BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MG II POROUS TOTAL KNEE SYSTEM PEGGED TIBIA

    MDR report key: 2031366 · Received March 23, 2011

    Report

    Report Number
    1822565-2011-00719
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    November 25, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: ONLY THE PART AND LOT NUMBER OF THE TIBIAL BASEPLATE WAS RECEIVED. PRE-OPERATIVE AND POST OPERATIVE X-RAYS WERE NOT AVAILABLE TO ANALYZE THE FIXATION. SURGEON NOTES ARE ALSO NOT AVAILABLE TO UNDERSTAND THE REASON FOR BREAKAGE. HOWEVER, PHOTOGRAPHS OF THE EXPLANTED PRODUCTS WERE PROVIDED AND EXHIBIT SEVERE FRACTURE OF THE TIBIAL BASEPLATE AND ARTICULAR SURFACE COMPONENTS. THIS COULD BE DUE TO SOME INJURIES INFLICTED BY THE PT, BUT CANNOT BE CONFIRMED. WITH THE AVAILABLE INFORMATION, PROBABLE CAUSE FOR BREAKAGE OF ARTICULAR SURFACE AND TIBIAL BASE PLATE CANNOT BE CONFIRMED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR THE TIBIAL BASEPLATE DID NOT FIND ANY DEVIATIONS OR ANOMALIES. REVIEW OF THE DHR FOR THE ARTICULAR SURFACE WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 INFORMATION 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 WAS REVISED DUE TO BREAKAGE OF KNEE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MG II POROUS TOTAL KNEE SYSTEM PEGGED TIBIA JWH ZIMMER INC 72516200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN ZIMMER ARTICULAR SURFACE| CATALOG # UNK, LOT # UNK