BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 7267960 · Received February 13, 2018

    Report

    Report Number
    0002249697-2018-00405
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    January 16, 2018
    Report Date
    March 23, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION LOT # AND EXPIRATION DATE, MANUFACTURING DATE. DEVICE EVALUATED BY MFG. AN EVENT REGARDING LOOSENING INVOLVING A SCORPIO BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: ONE BASEPLATE CATALOG # 7155-0005 LOT CODE K2KMNA AND INSERT CATALOG # 72-13-0515 LOT CODE UNKNOWN WERE RETURNED FOR EVALUATION. THERE IS YELLOWING AND PITTING ON THE SUPERIOR SURFACE OF THE INSERT. EXPLANATION DAMAGE IS ALSO VISIBLE ON THE INSERT. THE DAMAGE TO INSERT AND BASEPLATE COMPONENTS IS CONSISTENT WITH IN VIVO USE AND EXPLANTATION DAMAGE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE EVENT ITSELF COULD NOT BE CONFIRMED NOR COULD THE EXACT CAUSE OF THE EVENT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER SCORPIO PS KNEE WAS PARTIALLY REVISED TO A SCORPIO TS REVISION TIBIA. IT WAS REPORTED THAT THE ORIGINAL IMPLANTS WERE IMPLANTED IN 2008. IT WAS REPORTED THAT THE REASON FOR REVISION WAS ASCEPTIC LOOSENING. TOURNIQUET TIME: 118 MIN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STRYKER SCORPIO PS KNEE WAS PARTIALLY REVISED TO A SCORPIO TS REVISION TIBIA. IT WAS REPORTED THAT THE ORIGINAL IMPLANTS WERE IMPLANTED IN 2008. IT WAS REPORTED THAT THE REASON FOR REVISION WAS ASCEPTIC LOOSENING. TOURNIQUET TIME: 118MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109774 SERIES 7000 STANDARD TIBIA PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH K2KMNA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R