BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMAL FEMUR

    MDR report key: 8052031 · Received November 8, 2018

    Report

    Report Number
    3004105610-2018-00111
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    October 12, 2018
    Report Date
    May 9, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING ALLEGED FEMORAL STEM LOOSENING INVOLVING A PATIENT SPECIFIC PROXIMAL FEMUR REPLACEMENT WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. CLINICIAN REVIEW: THE IMPLANT IN SITU WAS FOR A PROXIMAL FEMORAL REPLACEMENT WHICH WAS INSERTED ON (B)(6) 2011. NOW THE SURGEON HAS REPORTED THAT THE IMPLANT HAD AN ASEPTIC LOOSENING. THE IMAGING SHOWS THAT THE PATIENT HAD A SIGNIFICANT BONE ABSORPTION ON THE REMAINING FEMUR WHICH LEFT A VERY THIN CORTEX. THERE IS A MASSIVE RADIOLUCENT LINE ALONG THE STEM AND THE IMPLANT APPEARS TO HAVE ASEPTIC LOOSENING. THEREFORE THE RADIOGRAPHIC ASSESSMENT HAS CONFIRMED THE REASON FOR REVISION. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 26AUG2011 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN 1 OTHER EVENT RELEVANT TO THIS INVESTIGATION. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED. REVISION SURGERY TOOK PLACE ON (B)(6) 2019 DUE TO LOOSENING WHEREBY PATIENT SPECIFIC PROXIMAL FEMORAL COMPONENTS WERE EXPLANTED SIW WILL CONTINUE TO MONITOR FOR TRENDS. CORRECTIVE ACTION/PREVENTIVE ACTION: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF A LEFT PROXIMAL FEMUR AND ENDOPROSTHETIC REPLACEMENT IS NEEDED.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. PLEASE NOTE THAT THIS PATIENT SPECIFIC IMPLANT IS SIMILAR TO THE METS MODULAR PROXIMAL FEMUR IMPLANT (K121056). DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION OF A LEFT PROXIMAL FEMUR AND ENDOPROSTHETIC REPLACEMENT IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891559 PROXIMAL FEMUR LIMB SALVAGE SYSTEM JDI STANMORE IMPLANTS WORLDWIDE PIN 16505

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R SIW CERAMIC FEMORAL HEAD 28MM STD| SIW CERAMIC FEMORAL HEAD 28MM+3.5| SIW CERAMIC FEMORAL HEAD 28MM-3.5