BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN METS DISTAL FEMUR

    MDR report key: 13966988 · Received March 31, 2022

    Report

    Report Number
    3004105610-2022-00047
    Event Type
    Injury
    Date Received
    March 31, 2022
    Date of Event
    May 18, 2021
    Report Date
    March 31, 2022
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    THIS PI IS FOR DISARTICULATION AT THE HIP AFTER INFECTION. THE FOLLOWING IS REPORTED IN ELSEVIER'S THE KNEE JOURNAL ISSUE 31 (2021) 97-109, DISTAL FEMORAL REPLACEMENT - DOES LENGTH MATTER? MID-TERM RESULTS FOR DISTAL FEMORAL REPLACEMENTS (A STUDY OF 90 PATIENTS WAS REVIEWED. AS PER DEMOGRAPHICS PROVIDED, 43 PATIENTS WERE SUBJECT TO REVISION ARTHROPLASTY AND THE REMAINING 47 PATIENTS REFLECT TUMOR SURGERY. PATIENT GENDERS ARE LISTED AS 47 MALES AND 43 FEMALES, MEDIAN AGE 71 FOR PATIENT'S SUBJECT TO REVISION ARTHROPLASTY, ALL OF WHOM HAD A STANMORE DISTAL FEMORAL METS IMPLANTED BETWEEN 2002 AND 2019):: "ONE PATIENT...WITH FAILURE OF HIS EXTENSOR MECHANISM HAD TO BE REVISED AND UNFORTUNATELY BECAME INFECTED. HE SUBSEQUENTLY REQUIRED A DISARTICULATION AT THE HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043429 UNKNOWN METS DISTAL FEMUR PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention| H