BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT

    MDR report key: 4534801 · Received February 17, 2015

    Report

    Report Number
    3004105610-2015-00013
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    PMA / PMN Number
    K121056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS CONFIRMS THAT THE DEVICE WAS MANUFACTURED TO SPEC AND THAT NO NON-CONFORMITIES WERE IDENTIFIED. THE DEVICE IS NOT AVAILABLE FOR EVAL. THE INVESTIGATION IS ONGOING, A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON COMPLETION. PLEASE NOTE THAT THE KTS PROXIMAL FEMUR REPLACEMENT IMPLANT IS SIMILAR TO METS MODULAR PROXIMAL FEMUR (K121056).

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT SUCCESSFUL REVISION OF THE CUSTOM PROXIMAL FEMUR JTS. AS DOCUMENTED IN THE ORIGINAL INVESTIGATION, THE REAMER DIMENSION WAS NOT ON THE DRAWING AS IT WAS CLEARLY VISIBLE ON THE SIDE OF THE DEVICE AND THE DIMENSION WAS AS SPECIFIED BY THE SURGEON (NOT SPECIFIED BY STANMORE IMPLANTS). THE REAMER WAS MADE TO THE SURGEON'S SPECIFIED DIMENSIONS BY SUBCONTRACTED MANUFACTURER. THE SUBCONTRACT MANUFACTURER SUPPLIED CERTIFICATES OF CONFORMITY AND INSPECTION CERTIFICATES TO STANMORE IMPLANTS. THE SURGEON APPROVED THE DESIGN PROPOSAL, WHICH DID NOT INCLUDE THE REAMER DIMENSIONS AND THE REAMER WAS ALSO APPROVED AS A SEPARATE PICTURE. THE SURGEON'S COMPLAINT THAT THE REAMER DIMENSIONS WERE MISSING FROM THE DRAWING IS UNFOUNDED AS HE HAD ALREADY APPROVED THE DESIGN PROPOSAL DRAWING WHICH DID NOT INCLUDE THE REAMER OR ITS DIMENSION. THE SURGEON'S COMPLAINT THAT THE REAMER DID NOT WORK COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE SURGEON HAS STATED THAT HE DOES NOT WANT THIS STYLE OF REAMER AGAIN WHICH INDICATES THAT THIS COULD BE DUE TO THE SURGEON'S PREFERENCE NOT A FAULT WITH THE REAMER, (NOTE THAT THE SURGEON HAD SEEN AND APPROVED THE REAMER BEFORE IT WAS DISPATCHED TO HIM). NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. THE COMPLAINT IS BEING CLOSED AND TRACKED AND TRENDED. CORRECTED DATA: COMMON DEVICE NAME/PRODUCT CODE WAS CORRECTED FROM "PROSTHESIS, KNEE, FEMEROTIBIAL, COTS/KRO" TO "LIMB SALVAGE SYSTEM/JDI".

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A PROCEDURE TO IMPLANT A JTS PROXIMAL FEMUR REPLACEMENT IMPLANT IT WAS NOTED THAT THE CUSTOM ACETABULAR REAMER DIMENSION WAS MISSING FROM THE OP DRAWING. ADDITIONALLY THE REAMER SUPPLIED DID NOT WORK RESULTING IN THE SURGEON HAVING TO USE REAMERS FROM HOSP STOCK.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING A PROCEDURE TO REPLACE A JTS PROXIMAL FEMUR REPLACEMENT IMPLANT IT WAS NOTED THAT THE CUSTOM ACETABULAR REAMER DIMENSION WAS MISSING FROM THE OP DRAWING. ADDITIONALLY THE REAMER SUPPLIED DID NOT WORK, RESULTING IN THE SURGEON HAVING TO USE A REAMER FROM HOSPITAL STOCK. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2015-00013 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112319 CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD BME19099 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other