BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE REPLACEMENT (REVISION)

    MDR report key: 9150513 · Received October 3, 2019

    Report

    Report Number
    3004105610-2019-00109
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 6, 2019
    Report Date
    December 9, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K140900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A PATIENT SPECIFIC TOTAL KNEE 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 DISTAL FEMORAL REPLACEMENT INSERTED ON (B)(6) 2018 THE SURGEON REPORTED THAT A PERIPROSTHETIC FRACTURE HAS OCCURRED. THE MEDICAL IMAGING PROVIDED SHOWED THAT FEMORAL BONE HAS FRACTURED AT LEVEL BETWEEN THE HIP AND DISTAL FEMORAL STEM WHICH CONFIRMS 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 09 NOV 2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 02OCT2016 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING A PERIPROSTHETIC FRACTURE INVOLVING A PATIENT SPECIFIC TOTAL KNEE REPLACEMENT. THERE HAVE BEEN NO OTHER EVENTS. CONCLUSIONS: AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A PATIENT SPECIFIC TOTAL KNEE REPLACEMENT WAS REPORTED. THE EVENT WAS CONFIRMED BY MEDICAL REVIEW AND PATIENT BMI WAS REPORTED TO BE 42. 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/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 THAT ". . . [PATIENT] HAS A PERIPROSTHETIC FRACTURE AND WOULD THEREFORE LIKE A CEMENT OVER DFR. PATIENT HAS BEEN INITIALLY SCHEDULED FOR 4 WEEKS TIME (THIS IS URGENT AS SHE IS CURRENTLY LYING IMMOBILISED IN A HOSPITAL BED)."

    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. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT " [PATIENT] HAS A PERIPROSTHETIC FRACTURE AND WOULD THEREFORE LIKE A CEMENT OVER DFR. PATIENT HAS BEEN INITIALLY SCHEDULED FOR 4 WEEKS TIME (THIS IS URGENT AS SHE IS CURRENTLY LYING IMMOBILISED IN A HOSPITAL BED)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945808 TOTAL KNEE REPLACEMENT (REVISION) PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 21529

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R