BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METS PROXIMAL FEMUR

    MDR report key: 3954848 · Received July 17, 2014

    Report

    Report Number
    3004105610-2014-00001
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    KRO
    PMA / PMN Number
    K121056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION TO A PROXIMAL FEMUR. THE SURGERY WAS REQUIRED DUE TO A PATIENT INFECTION WHICH WAS NOT ATTRIBUTED TO THE DEVICE WHICH HAD BEEN IMPLANTED TWO YEARS EARLIER. THE REVISION SURGERY WAS COMPLETED WITH NO REPORTED COMPLICATIONS. THIS COMPLAINT IS BEING CLOSED, AND IS BEING TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION IS PENDING. ADDITIONAL INFORMATION FROM THE CLINICIAN IS REQUIRED. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON RECEIPT OF THE ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IN A LETTER DATED (B)(6) 2014, THE PHYSICIAN CONTACTED THE COMPANY'S DESIGN OFFICE REGARDING A PATIENT WITH A MET PROXIMAL FEMORAL REPLACEMENT IN SITU, WITH CURRENTLY THE SMALLEST PROXIMAL FEMUR REPLACEMENT (BELIEVED TO BE A "10 X 37 CM STEM WITH A SMALL BODY"). HE FURTHER STATED THAT "UNFORTUNATELY, AFTER REMOVAL OF THE TROCHANTERIC PLATE AND SCREWS SHE BECAME INFECTED. "THE CLINICIAN REQUESTED THAT THE COMPANY MANUFACTURE "A SILVER TREATED MONO BLOCK PROSTHESIS TAKING INTO ACCOUNT A RESECTION LEVEL OF 1 CM FURTHER DOWN THE FEMUR. "THE CLINICIAN ALSO ADVISED THAT THE SURGICAL REVISION IS TENTATIVELY SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    IN A LETTER DATED (B)(6) 2014, THE PHYSICIAN CONTACTED THE COMAPNY'S DESIGN OFFICE REGARDING A PATIENT WITH A METS PROXIMAL FEMORAL REPLACEMENT IN SITU, WITH CURRENTLY THE SMALLEST PROXIMAL FEMUR REPLACEMENT (BELIEVED TO BE A "10 X 37 CM STEM WITH A SMALL BODY"). HE FURTHER STATED THAT "UNFORTUNATELY, AFTER REMOVAL OF THE TROCHANTERIC PLATE AND SCREWS SHE BECAME INFECTED". THE CLINICIAN REQUESTED THAT THE COMPANY MANUFACTURE A "A SILVER TREATED MONO BLOCK PROSTHESIS TAKING INTO ACCOUNT A RESECTION LEVEL OF 1 CM FURTHER DOWN THE FEMUR". THE CLINICIAN ALSO ADVISED THAT THE SURGICAL REVISION IS TENTATIVELY SCHEDULED FOR (B)(6) 2014. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-0001 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420166 METS PROXIMAL FEMUR LIMB SALVAGE SYSTEM KRO STANMORE IMPLANTS WORLDWIDE LTD CRC2323 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other