BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEM KNEE W/EPI R SM

    MDR report key: 9597446 · Received January 16, 2020

    Report

    Report Number
    3004105610-2020-00010
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    December 21, 2019
    Report Date
    March 18, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K121029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: B5 METS TOTAL FEMUR CORRECTED TO METS DISTAL FEMUR. G5 K121055 CORRECTED TO K121029. ADDITIONAL MANUFACTURER NARRATIVE REPORTED EVENT AN EVENT REGARDING ALLEGED LIMB LENGTH DISCREPANCY INVOLVING A METS DISTAL FEMUR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION OF PICTURES OF PART OF THE RETRIEVED DEVICE WAS RECEIVED. THE PICTURES SHOWS THAT THE DISTAL PART OF THE DEVICE (FEMORAL COMPONENT) IS CLEARLY VISIBLE AND IT DOES NOT SHOW EVIDENT SIGNS OF DAMAGE, WHILST THE MOST PROXIMAL PART OF IT IS COVERED BY TISSUE. CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 03OCT2011 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FOR SIMILAR EVENTS REGARDING LIMB LENGTH DISCREPANCY. LOT B9088/001. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: AN EVENT REGARDING ALLEGED LIMB LENGTH DISCREPANCY INVOLVING A METS DISTAL FEMUR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND 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/OR INSUFFICIENT INFORMATION WAS RECEIVED BY SIW. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE RE-OPENED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THE SURGEON WILL REVISE A METS DISTAL FEMUR.

    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THE SURGEON WILL REVISE A METS TOTAL FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60009 FEM KNEE W/EPI R SM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE B9088/001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R