BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DUR REG FLUTED STEM16X155MM

    MDR report key: 8544202 · Received April 24, 2019

    Report

    Report Number
    0002249697-2019-01694
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    March 5, 2019
    Report Date
    June 5, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    UDI-DI
    07613327045031
    PMA / PMN Number
    K973164
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TI DUR REG FLUTED STEM16X155MM; CAT#: 64786715; LOT#: T1179. TI DUR REG FLUTED STEM 18X80MM; CAT#: 64786640; LOT#: UNKNOWN. MRH TIB ROT COMP XS-XL; CAT#: 64812100; LOT#: UNKNOWN. MRHK TIB INS 10MM XS/S S1/S2; CAT#: 64813210; LOT#: LBY029. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVENT REGARDING CRACK/FRACTURE INVOLVING A DURACON STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 0

    ASEPTIC MOBILIZATION OF LEFT KNEE PROSTHESIS WITH BROKEN STEM IMPLANTED ON 2011.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TI DUR REG FLUTED STEM16X155MM; CAT# 64786715; LOT# T1179. TI DUR REG FLUTED STEM 18X80MM; CAT# 64786640; LOT# UNKNOWN. MRH TIB ROT COMP XS-XL; CAT# 64812100; LOT# UNKNOWN. MRHK TIB INS 10MM XS/S S1/S2; CAT# 64813210; LOT# LBY029. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ASEPTIC MOBILIZATION OF LEFT KNEE PROSTHESIS WITH BROKEN STEM IMPLANTED ON 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338008 TI DUR REG FLUTED STEM16X155MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META JWH STRYKER ORTHOPAEDICS-MAHWAH T1179 07613327045031

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R