BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PMMA PRECOAT PEGGED TIBIAL COMPONENT

    MDR report key: 3925663 · Received June 17, 2014

    Report

    Report Number
    2648920-2014-00153
    Event Type
    Injury
    Date Received
    June 17, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: COMPATIBILITY WAS VERIFIED WITH NO ISSUES NOTED. OPERATIVE NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE COMPLAINT CANNOT BE CONFIRMED. BASED ON THE AVAILABLE INFO, A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. HOWEVER, THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFO. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS EXPERIENCING KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356448 NEXGEN PMMA PRECOAT PEGGED TIBIAL COMPONENT JWH ZIMMER 61864207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LOT #61905925| NEXGEN CR-FLEX GSF PRECOAT FEMORAL COMPONENT:| CATALOG #00575001502, LOT #61917776 - MANUFACTURED| (B)(4)| NEXGEN CR ARTICULAR SURFACE: CATALOG #90597003010,| LOT #61935201 - MANUFACTURED BY ZIMMER INC. -| NEXGEN ALL POLY PATELLA: CATALOG #00597206529,| BY ZIMMER LTD. - (B)(4)