BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 15803134 · Received November 16, 2022

    Report

    Report Number
    0009613350-2022-00593
    Event Type
    Injury
    Date Received
    November 16, 2022
    Report Date
    January 24, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURER GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#: UNKNOWN; LOT#; UNKNOWN; ITEM NAME: UNKNOWN DISTAL LOCKING SCREW; ITEM#: UNKNOWN; LOT#; UNKNOWN; ITEM NAME: UNKNOWN DISTAL LOCKING SCREW; ITEM#: UNKNOWN; LOT#; UNKNOWN; ITEM NAME: UNKNOWN DISTAL LOCKING SCREW; ITEM#: UNKNOWN; LOT#; UNKNOWN; ITEM NAME: UNKNOWN DISTAL LOCKING SCREW; ITEM#: UNKNOWN; LOT#; UNKNOWN; ITEM NAME: UNKNOWN DISTAL LOCKING SCREW. REPORT SOURCE-FOREIGN-UNITED KINGDOM. LITERATURE-JOURNAL ARTICLE. THE OUTCOME OF FIXING DISTAL FEMUR PERIPROSTHETIC FRACTURE AROUND TOTAL KNEE REPLACEMENT USING A LOCKING PLATE NON-CONTACT BRIDGING (NCB). RAHUMA MA, NOUREDDINE H. DOI: HTTPS://DOI.ORG/10.5704/MOJ.2203.007. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    A STUDY REPORTED THE ONE 75-YEAR-OLD FEMALE PATIENT WITH A SU TYPE 3 FRACTURE EXPERIENCED MALUNION OF 11 DEGREES ANTERIOR ANGULATION POSTOP. NO FURTHER INTERVENTION OR COMPLICATIONS WERE NOTED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351574 UNKNOWN NCB PLATE TRAUMA PROSTHESIS HRS ZIMMER SWITZERLAND MANUFACTURER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other