BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REF FSO 9 70MM OD

    MDR report key: 21566981 · Received March 10, 2025

    Report

    Report Number
    1020279-2025-00457
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 10, 2025
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    UDI-DI
    03596010197146
    PMA / PMN Number
    K932755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A REPORTED PATIENT COMPLICATION THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE OF A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER SECOND RIGHT THA REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 (CASE-(B)(4), THE PATIENT EXPERIENCED AN INFECTED JOINT THAT WAS NOT IMPROVING SO UNDER A DIFFERENT SURGEON IT WAS DECIDED TO DO A 1ST STAGE REVISION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ALL COMPONENTS WERE REMOVED, THE REF FSO 9 70MM OD AND THE REF XLPE 28 20 DEG 70-76 K WERE EXPLANTED, ALONG WITH STRYKER ABG I STEM AND 28MM FEMORAL HEAD. THE JOINT WAS THOROUGHLY DEBRIDED AND WASHED. IT IS UNKNOWN WHEN THE 2ND STAGE REVISION WILL BE PLANNED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032539 REF FSO 9 70MM OD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. 91107619 03596010197146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R REF XLPE 28 20 DEG 70-76 K:71333329,15HM15715.