BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCA MTK REV TIB INS LT MED16MM

    MDR report key: 3123571 · Received May 22, 2013

    Report

    Report Number
    0002249697-2013-01739
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K972863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING WEAR/INSTABILITY INVOLVING A PCA INSERT WAS REPORTED. THE WEAR WAS CONFIRMED. VISUAL INSPECTION: "DELAMINATION WAS ALSO OBSERVED ON THE CENTRAL EMINENCE OF THE DEVICE. DELAMINATION OCCURS AS A RESULT OF CYCLIC CONTACT STRESSES BETWEEN THE FEMORAL COMPONENT AND THE INSERT INDUCED BY LOADING FROM PATIENT ACTIVITIES." "THE INSERT MATERIAL WAS SLIGHTLY DISCOLORED NEAR THE AREA OF DELAMINATION." "DAMAGE TO THE DISTAL SURFACE INCLUDED SCRATCHES AND INDENTATIONS FROM EMBEDDED THIRD BODY DEBRIS." THE MAR CONCLUDED: "IN-VIVO SERVICE RELATED DAMAGES TO THE ARTICULATING SURFACE INCLUDED THE CYCLIC FATIGUE MECHANISM OF DELAMINATION, AS WELL AS BURNISHING AND SCRATCHING. THESE ARE COMMONLY IDENTIFIED DAMAGE MODES ON UHMWPE TIBIAL INSERTS. THE YELLOW DISCOLORATION IS ATTRIBUTED TO IN-VIVO ABSORPTION OF SYNOVIAL FLUID. THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS ON THE RETURNED ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) TIBIAL INSERT." CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED HOWEVER A MATERIAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE WAS NO EVIDENCE OF A MATERIAL OR MANUFACTURING RELATED DEFECT. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES AND X RAYS ARE HOWEVER NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    PATIENT HAD INSTABILITY. A 16MM INSERT WAS REMOVED AND RESOLVED WITH A 22MM.

    Description of Event or Problem · 1

    PATIENT HAD INSTABILITY. A 16MM INSERT WAS REMOVED AND RESOLVED WITH A 22MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225937 PCA MTK REV TIB INS LT MED16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention