BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ABGII STEM

    MDR report key: 13257061 · Received January 14, 2022

    Report

    Report Number
    0002249697-2022-00081
    Event Type
    Injury
    Date Received
    January 14, 2022
    Date of Event
    October 24, 2020
    Report Date
    May 30, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G1 MANUFACTURING SITE CORRECT TO SHC. AN EVENT REGARDING A CRACK/FRACTURE INVOLVING AN UNKNOWN ABG II STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT -DEVICE HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    PATIENT PRESENTED TO HOSPITAL WITH LEFT LATERAL THIGH PAIN, WHERE IT WAS FOUND THERE HAD BEEN A SECOND TRANSVERSE FRACTURE THROUGH THE PROSTHESIS OF THE STEM OF THE LEFT HIP.

    Description of Event or Problem · 0

    PATIENT PRESENTED TO HOSPITAL WITH LEFT LATERAL THIGH PAIN, WHERE IT WAS FOUND THERE HAD BEEN A SECOND TRANSVERSE FRACTURE THROUGH THE PROSTHESIS OF THE STEM OF THE LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682973 UNKNOWN ABGII STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R