BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH TIBIAL B/PLT KEEL SML 2

    MDR report key: 22724330 · Received August 6, 2025

    Report

    Report Number
    0002249697-2025-00820
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    February 11, 2013
    Report Date
    August 6, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327045314
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING INFECTION INVOLVING A MRH BASEPLATE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL (SAL) OF 10^-6 IN ACCORDANCE TO APPLICABLE ISO STANDARDS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING PATHOLOGY REPORTS, 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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 64768270; KMAX STEM EXTNR(S,M,L,XL)155MM; LOT# UNKNOWN CAT# 64952030; GMRS DIST FEM COMP STD L 65MM; LOT# UNKNOWN CAT# 64768260; KMAX STEM EXTNR(S,M,L,XL),80MM; LOT# UNKNOWN IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: PJI. ALL COMPONENTS REMOVED. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533010 MRH TIBIAL B/PLT KEEL SML 2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327045314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H