BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMAL FEMUR

    MDR report key: 4373319 · Received December 23, 2014

    Report

    Report Number
    3004105610-2014-00127
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE LTD
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND NO NON-CONFORMANCES WERE IDENTIFIED. CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE REPORTED EVENT. REQUESTS ARE BEING MADE FOR ADDITIONAL INFO AND A SUPPLEMENTAL REPORT WILL BE PROVIDED IF THIS INFO IS RECEIVED. PLEASE NOTE THAT THIS CUSTOM IMPLANT IS SIMILAR TO THE METS MODULAR TOTAL FEMUR IMPLANT (K121055).

    Additional Manufacturer Narrative · 1

    THE PROXIMAL FEMUR WAS SUCCESSFULLY IMPLANTED WITH NO REPORTED COMPLICATIONS, THE OMISSION OF THE STEM LENGTH FROM THE OPERATION DRAWING DID NOT RESULT IN ANY REPORTED ADVERSE EFFECT OR DELAY. NO PREVIOUS REPORTS HAVE BEEN RECORDED OF A DIMENSION THAT WAS NOT INCLUDED ON AN OPERATION DRAWING FOR THIS DEVICE. PER THE WORK INSTRUCTION KEY DIMENSIONS FOR BONE PREPARATION (TP AT 145 AND STEM TAPERS 10.5 > 9) WERE INCLUDED ON THE OPERATION DRAWING. STEM LENGTH IS TYPICALLY INCLUDED ON OPERATION DRAWINGS BUT WAS OMITTED DUE TO HUMAN ERROR ON THIS OCCASION. NOTE THAT THE SURGEON APPROVED THE DESIGN PROPOSAL WHICH ALSO DID NOT INCLUDE THE STEM LENGTH. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTED DATA: CUSTOM TOTAL FEMORAL REPLACEMENT IMPLANT CORRECTED TO PROXIMAL FEMUR. TOTAL FEMORAL REPLACEMENT CORRECTED TO LIMB SALVAGE SYSTEM. IMPLANT DATE CORRECTED FROM (B)(6) 2011 TO (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP S. FRASER ON (B)(6) 2012 THAT IT WAS NOTED THE OP DRAWING DID NOT REFERENCE THE STEM LENGTH ON THE OP DRAWING. CASE WENT WELL, REGARDLESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP (B)(6) ON (B)(6) 2012 THAT IT WAS NOTED THE OP DRAWING DID NOT REFERENCE THE STEM LENGTH ON THE OP DRAWING. CASE WENT WELL, REGARDLESS. THIS IS A SUPPLEMENTAL REPORT TO 3004105610-2014-00127 ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847144 PROXIMAL FEMUR LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE LTD BME17549

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention