BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO U-DOME X3 PATELLA

    MDR report key: 8285946 · Received January 29, 2019

    Report

    Report Number
    0002249697-2019-00365
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 4, 2019
    Report Date
    June 12, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    UDI-DI
    07613327014570
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING CRACK/FRACTURE AND REVISION DUE TO MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE INVOLVING A SCORPIO PATELLA WAS REPORTED. THE EVENT OF CRACK/FRACTURE WAS CONFIRMED BASED ON THE MAR OF THE RETURNED DEVICE. THE EVENT OF REVISION DUE TO MCL FAILURE IS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: THE RETURNED DEVICES WERE EXAMINED WITH THE AID OF A STEREOMICROSCOPE AT MAGNIFICATIONS UP TO 200X. THIS INSPECTION INDICATED THE FRACTURE MORPHOLOGY OF THE PATELLA INSERT WAS CONSISTENT WITH OVERLOAD. THE DAMAGE PRESENT ON THE ARTICULATING SURFACE OF THE PATELLA INSERT WAS CONSISTENT WITH SCRATCHING AND THIRD BODY INDENTATIONS; WHICH ARE COMMON DAMAGE MODES OF UHMWPE. DIMENSIONAL AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE DEVICE WERE RETURNED DAMAGED. MATERIAL ANALYSIS IS NOT COMPLETED AS THE EVENT IS NOT RELATED TO THE MATERIAL INTEGRITY. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL RECORDS WERE DEEMED INSUFFICIENT BY A CLINICAL CONSULTANT INDICATED: PROVIDED IMAGE SHOWED FRACTURED PATELLA. NEED OPERATIVE REPORTS, CLINICAL/OFFICE NOTES, HISTOPATHOLOGY REPORTS, SERIAL X-RAYS AND EXAMINATION OF THE EXPLANTED COMPONENTS. DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. CONCLUSION: THE INVESTIGATION CONCLUDED THAT CRACK/FACTURE OF THE PATELLA WAS CAUSED BY OVERLOAD. THIS INSPECTION INDICATED THE FRACTURE MORPHOLOGY OF THE PATELLA INSERT WAS CONSISTENT WITH OVERLOAD. THE DAMAGE PRESENT ON THE ARTICULATING SURFACE OF THE PATELLA INSERT WAS CONSISTENT WITH SCRATCHING AND THIRD BODY INDENTATIONS; WHICH ARE COMMON DAMAGE MODES OF UHMWPE. THE ROOT CAUSE OF THE MCL FAILURE COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    ON (B)(6) 2013 TKA PROCEDURE DONE. THE PRODUCTS #81-4406R, #OR-7115-0005, #82-7-0512,#73-20-3508 WERE IMPLANTED IN PATIENT. ON (B)(6) 2019 PERFORMING TKA RE-REPLACEMENT SURGERY WITH MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE.THE REPLACEMENT IMPLANT IS COMPETITOR 360. IMPLANTED PEG WAS BROKEN AND THE 73-20-3508 X3 PATELLA UNIVERSAL DOME WAS BROKEN ALSO.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, TKA PROCEDURE DONE. THE PRODUCTS #81-4406R, #OR-7115-0005, #82-7-0512,#73-20-3508 WERE IMPLANTED IN PATIENT. ON (B)(6) 2019, PERFORMING TKA RE-REPLACEMENT SURGERY WITH MCL (MEDIAL COLLATERAL LIGAMENT) FAILURE. THE REPLACEMENT IMPLANT IS COMPETITOR 360. IMPLANTED PEG WAS BROKEN AND THE 73-20-3508 X3 PATELLA UNIVERSAL DOME WAS BROKEN ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77092 SCORPIO U-DOME X3 PATELLA PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY NPJ STRYKER ORTHOPAEDICS-MAHWAH UNK 07613327014570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R