BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NCB PLATE

    MDR report key: 15803066 · Received November 16, 2022

    Report

    Report Number
    0009613350-2022-00601
    Event Type
    Injury
    Date Received
    November 16, 2022
    Report Date
    January 26, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HRS
    PMA / PMN Number
    N/A
    Removal / Correction 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: UNKNOWN DISTAL LOCKING SCREW; ITEM#UNKNOWN DISTAL LOCKING SCREW; LOT#UNKNOWN; UNKNOWN DISTAL LOCKING SCREW; ITEM#UNKNOWN DISTAL LOCKING SCREW; LOT#UNKNOWN; UNKNOWN DISTAL LOCKING SCREW; ITEM#UNKNOWN DISTAL LOCKING SCREW; LOT#UNKNOWN; UNKNOWN DISTAL LOCKING SCREW; ITEM#UNKNOWN DISTAL LOCKING SCREW; LOT#UNKNOWN. REPORT SOURCE - 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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D9; G3; G6; H2; H3; H6; H10 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. THE DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PART AND LOT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A REVISION ARTHROPLASTY WITH A LONG STEM CEMENTED PROSTHESIS DUE TO FRACTURE NONUNION. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    349591 UNKNOWN NCB PLATE TRAUMA PROSTHESIS HRS ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Hospitalization| O SEE H10 NARRATIVE