BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SP TOTAL KNEE REPLACEMENT

    MDR report key: 4955621 · Received July 31, 2015

    Report

    Report Number
    3004105610-2015-00070
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K120992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A SUCCESSFUL REVISION PROCEDURE WHICH CONSISTED OF A REBUSHING WITH ARTHRODESIS COMPONENTS PROVIDED BY STANMORE. NO EXPLANTED COMPONENTS WERE RETURNED FOR EVALUATION. STANMORE CANNOT ATTRIBUTE THE NEED FOR REBUSHING TO A DEFINITIVE CAUSE. THE COMPLAINT IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION WITH NO ABNORMALITIES OR DEVIATIONS. POSSIBLE REASONS FOR INSTABILITY INCLUDE LOOSE COMPONENTS OR A TIBIAL COMPONENT CENTRAL PEG FAILURE. HOWEVER, A REVIEW OF THE PATIENT'S X-RAYS DOES NOT SHOW ANY EVIDENCE OF COMPONENT LOOSENING. REGARDING A FAILURE OF THE CENTRAL PEG OF THE TIBIAL COMPONENT, THIS CAN ONLY BE CONFIRMED BY EXAMINING THE COMPONENTS DURING THE REVISION/FOLLOWING EXPLANT. FOLLOWING THE REVISION, THE EXPLANTED COMPONENTS ARE SCHEDULED TO BE RETURNED TO THE COMPANY FOR EVALUATION. ADDITIONAL COMPLAINT RELATED INFORMATION, INCLUDING THE RETURN OF THE DEVICE HAS BEEN REQUESTED FROM THE SURGEON. PLEASE NOTE THAT THIS CUSTOM DEVICE IS SIMILAR TO THE METS SMILES TOTAL KNEE REPLACEMENT (K120992). CURRENTLY IMPLANTED.

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED REPLACEMENT PLASTIC BEARING COMPONENTS IN ORDER TO CARRY OUT A REBUSHING PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON REPORTS THAT THE PATIENT IS EXPERIENCING INSTABILITY.

    Description of Event or Problem · 1

    THE SURGEON HAS REQUESTED REPLACEMENT PLASTIC BEARING COMPONENTS IN ORDER TO CARRY OUT A REBUSHING PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON REPORTS THAT THE PATIENT IS EXPERIENCING INSTABILITY. THE DATE OF THE REVISION PROCEDURE HAS NOT YET BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501838 SP TOTAL KNEE REPLACEMENT LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD PIN18201 PIN18201

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R