BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR RADIAL HEAD SZ. 20S WW

    MDR report key: 7491092 · Received May 7, 2018

    Report

    Report Number
    1651501-2018-00027
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    April 18, 2018
    Report Date
    April 20, 2018
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWI
    PMA / PMN Number
    K032686
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTAL HYGIENIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFR. REPORT NUMBER: 1651501-2018-0002.

    Additional Manufacturer Narrative · 1

    A METAL RADIAL HEAD IMPLANT WAS RETURNED. THE IMPLANT CONSISTED OF A HEAD COMPONENT SIZE 20S LOT 10-0192 AND A STEM COMPONENT SIZE 01 LOT 09-1864. AN INVESTIGATION OF THE DEVICE RECORDS WAS CONDUCTED BY THE MANUFACTURER FOR THE HEAD COMPONENT SIZE 20S LOT 10-0192. A VISUAL EXAMINATION OF THE COMPONENTS WAS PERFORMED ASSISTED BY A STEREOMICROSCOPE AND OBLIQUE LIGHTING. VISUAL EXAMINATION REVEALED AN INTACT IMPLANT, WITH THE STEM TO HEAD TAPER FIRMLY ENGAGED. THE HEAD ARTICULATING SURFACE RETAINED A BRIGHT ¿MIRROR-LIKE¿ POLISH, WITH NO APPARENT SCARRING FROM USE. THE RECORDS REVIEW FOUND THAT THE COMPONENTS SATISFIED ALL APPLICABLE MANUFACTURING SPECIFICATIONS. POTENTIAL ROOT CAUSE: APPARENT LOOSENING OF THE MRH IMPLANT DUE TO A TRAUMATIC INJURY.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS. IT WAS REPORTED THAT ON (B)(6) 2018, A PATIENT FELL AND COMPLAINED OF PAIN AND IMPAIRED RANGE OF MOTION WHILE AN MRH-350-20S-WW MODULAR RADIAL HEAD SZ. 20S WW WAS ATTACHED. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333235 MODULAR RADIAL HEAD SZ. 20S WW MODULAR RADIAL HEAD KWI ASCENSION ORTHOPEDICS 09-1864

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention