BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP PLATE SCREWS

    MDR report key: 12916694 · Received December 2, 2021

    Report

    Report Number
    0002249697-2021-02003
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 9, 2021
    Report Date
    December 2, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327037111
    PMA / PMN Number
    K943549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THIS PI IS FOR THE POST-REVISION OF THE PATIENT'S ACETABULAR SHELL. REP MADE AWARE ON (B)(6) 2021. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF PI CREATION. IT WAS REPORTED THAT A LEFT TOTAL HIP REPLACEMENT HAD A LOOSE ACETABULAR COMPONENT DONE FROM A PRIOR SURGERY, DATE UNKNOWN. UPON REVIEWING THE X RAYS IT WAS APPARENT THE CUP WAS LOOSE AND DISPLACED. DR REQUESTED A REVISION CUP, MDM LINER, INSERT AND HEAD. HE ALSO REQUESTED A NEW RESTORATION MODULAR BODY DUE TO THE PRE SURGERY IDENTIFICATION. THE PROCEDURE WAS PERFORMED THROUGH A POSTERIOR APPROACH. THE OLD CUP WAS REMOVED. THE NEW BODY, CUP LINER AND HEAD WERE IMPLANTED PER SURGICAL TECHNIQUE AS WELL AS 7 SCREWS INTO THE ACETABULUM. THE PATIENT APPEARED TO HAVE SATISFACTORY STABILITY AND LEG LENGTH PER DR. AN INTRA OPERATIVE X RAY WAS TAKEN TO CONFIRM THE PLACEMENT. SATISFIED DR CLOSED UP THE PROCEDURE. I WAS INFORMED YESTERDAY (B)(6) 2021 THAT THE NEW IMPLANTS HAVE AGAIN BECOME LOOSE AND DISLODGED FROM THE ACETABULUM. DR IS NOW IN THE PLANNING STAGES FOR A FOLLOW UP PROCEDURE." SPOKE TO REP, WHO PROVIDED THE USAGE SHEET FROM THE REVISION ON (B)(6) 2021. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, HEAD, OR RESTORATION MODULAR PROXIMAL BODY, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Description of Event or Problem · 0

    THIS PI IS FOR THE POST-REVISION OF THE PATIENT'S ACETABULAR SHELL. REP MADE AWARE ON (B)(6) 2021. PATIENT HAS NOT BEEN REVISED AS OF THE TIME OF PI CREATION. IT WAS REPORTED THAT A LEFT TOTAL HIP REPLACEMENT HAD A LOOSE ACETABULAR COMPONENT DONE FROM A PRIOR SURGERY, DATE UNKNOWN. UPON REVIEWING THE X RAYS IT WAS APPARENT THE CUP WAS LOOSE AND DISPLACED. DR REQUESTED A REVISION CUP, MDM LINER, INSERT AND HEAD. HE ALSO REQUESTED A NEW RESTORATION MODULAR BODY DUE TO THE PRE SURGERY IDENTIFICATION. THE PROCEDURE WAS PERFORMED THROUGH A POSTERIOR APPROACH. THE OLD CUP WAS REMOVED. THE NEW BODY, CUP LINER AND HEAD WERE IMPLANTED PER SURGICAL TECHNIQUE AS WELL AS 7 SCREWS INTO THE ACETABULUM. THE PATIENT APPEARED TO HAVE SATISFACTORY STABILITY AND LEG LENGTH PER DR. AN INTRA OPERATIVE X RAY WAS TAKEN TO CONFIRM THE PLACEMENT. SATISFIED DR CLOSED UP THE PROCEDURE. I WAS INFORMED YESTERDAY (B)(6) 2021 THAT THE NEW IMPLANTS HAVE AGAIN BECOME LOOSE AND DISLODGED FROM THE ACETABULUM. DR IS NOW IN THE PLANNING STAGES FOR A FOLLOW UP PROCEDURE." SPOKE TO REP, WHO PROVIDED THE USAGE SHEET FROM THE REVISION ON (B)(6) 2021. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, HEAD, OR RESTORATION MODULAR PROXIMAL BODY, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815897 GAP PLATE SCREWS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 2080-0025 9M03PN 07613327037111

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other