BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3092105 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01509
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE RETURNED INSERT IS IN USED CONDITION. THERE ARE MINOR SCRATCHES AND MARKINGS ON THE PROXIMAL SURFACE. THERE ARE SEVERE SCRATCHES AND INDENTATIONS ON THE DISTAL SURFACES. THE ANTERIOR LOCKING WIRE IS INTACT AND IN GOOD CONDITION. A MATERIAL ANALYSIS WAS PERFORMED. THE REPORT CONCLUDED: "BURNISHING AND SCRATCHING WERE OBSERVED ON THE ARTICULATING SURFACE AND ARE CONSISTENT WITH COMMONLY IDENTIFIED DAMAGE MODES IN UHMWPE INSERTS. DAMAGE TO THE DISTAL SIDE AND THE ANTERIOR LOCKING MECHANISM OF THE INSERT SUGGESTS THAT THE TRIATHLON TIBIAL INSERT MAY NOT HAVE BEEN PROPERLY SEATED DURING INITIAL IMPLANTATION. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED DURING THIS EXAMINATION." THE EVENT WAS CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS NOT CAUSED BY MANUFACTURING FACTORS. RATHER, IT IS LIKELY THE TIBIAL INSERT WAS NOT SEATED PROPERLY DURING IMPLANTATION.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS PATIENT'S PRIMARY TOTAL KNEE REPLACEMENT WAS DONE ON (B)(6) 2011 BY DR (B)(6) AT (B)(6)HOSPITAL. SHE WAS BROUGHT BACK IN TO THE O.R. FOR A "POLY SWAP" ON (B)(6) 2013 AT (B)(6) HOSPITAL. DR (B)(6) DID THIS PROCEDURE. ON (B)(6) 2013 DR (B)(6) BROUGHT HER BACK IN TO THE O.R. TO REVISE HER POLY INSERT. DR (B)(6) REMOVED THE FAILED POLY WITHOUT ANY DIFFICULTY, AND REPLACED IT WITH ANOTHER IDENTICAL POLY.

    Description of Event or Problem · 1

    THIS PATIENT'S PRIMARY TOTAL KNEE REPLACEMENT WAS DONE ON (B)(6) 2011 BY DR. (B)(6) AT (B)(6) HOSPITAL. SHE WAS BROUGHT BACK IN TO THE O.R. FOR A "POLY SWAP" ON (B)(6) 2013 AT (B)(6) HOSPITAL. DR (B)(6) DID THIS PROCEDURE. ON (B)(6) 2013, DR (B)(6) BROUGHT HER BACK IN TO THE O.R. TO REVISE HER POLY INSERT. DR (B)(6) REMOVED THE FAILED POLY WITHOUT ANY DIFFICULTY, AND REPLACED IT WITH ANOTHER IDENTICAL POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194413 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLD6HP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention