BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISTAL FEMUR JTS

    MDR report key: 8645669 · Received May 28, 2019

    Report

    Report Number
    3004105610-2019-00067
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 30, 2019
    Report Date
    August 30, 2019
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    PMA / PMN Number
    K133152
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING LOOSENING INVOLVING A JTS DISTAL FEMUR WAS REPORTED. THE EVENT WAS CONFIRMED BY X-RAY REVIEW. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. CLINICIAN REVIEW: A REVIEW OF THE X-RAY IMAGES BY CLINICAL CONSULTANT INDICATED: "THE IMPLANT IN SITU WAS FOR JTS DISTAL FEMORAL REPLACEMENT, WHICH WAS INSERTED ON (B)(6) 2008. THE SURGEON REPORTED ASEPTIC LOOSENING OF THE IMPLANT. THE CT SCAN PROVIDED SHOWED A MASSIVE RADIOLUCENT LINE AROUND THE IMPLANT AND THE CEMENT MANTLE HAS BEEN FRAGMENTED. IN ADDITION, THE FEMORAL BONE HAS FRACTURED AT THE TIP OF THE STEM. ALL THESE RADIOGRAPHIC OBSERVATIONS CAN CONFIRM THE REASON FOR REVISION." PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATES 1 DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 30JUN2008 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION THE COMPLAINT DATABASES WERE REVIEWED FROM 30APR2016 FOR SIMILAR EVENTS REGARDING LOOSENING OF A JTS DISTAL FEMUR. THERE HAVE BEEN 4 OTHER EVENTS. CONCLUSIONS: AN EVENT REGARDING LOOSENING INVOLVING A JTS DISTAL FEMUR WAS REPORTED. THE DEVICE REMAINED IN SITU FOR 11 YEARS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS ANALYSIS OF THE RETRIEVED DEVICE 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. 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    A PATIENT SPECIFIC PRESCRIPTION FORM WAS SUBMITTED FOR A PATIENT'S LEFT DISTAL FEMUR. NOTES INDICATE "REVISION, NIG, SILVER, DFR, EXTRACORTICAL PLATE, AND SCREW IN FEMORAL NECK." THE REASON FOR REVISION IS DUE TO ASEPTIC LOOSENING. UPDATE (B)(6) 2019: THE SURGEON HAS CONFIRMED THE REASON FOR REVISION IS DUE TO ASEPTIC LOOSENING.

    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

    A PATIENT SPECIFIC PRESCRIPTION FORM WAS SUBMITTED FOR A PATIENT'S LEFT DISTAL FEMUR. NOTES INDICATE "REVISION, NIG, SILVER, DFR, EXTRACORTICAL PLATE, AND SCREW IN FEMORAL NECK ". THE REASON FOR REVISION IS DUE TO ASEPTIC LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439271 DISTAL FEMUR JTS PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE PIN 13877

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R PASSIVE GROWER BEARING (B5158).| SMBPR02 (B5034) BUMPER PAD.| SMBSH02 (B5033) BUSHES.| SMCIC01 (B5417) CIRCLIP.