BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE THREAD 9X30MM FULL THRD

    MDR report key: 16138334 · Received January 11, 2023

    Report

    Report Number
    0001825034-2023-00064
    Event Type
    Injury
    Date Received
    January 11, 2023
    Date of Event
    January 3, 2011
    Report Date
    January 27, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    UDI-DI
    00880304006676
    PMA / PMN Number
    K041274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT: 905617 LOT: 510340 GENTLE THREAD 9X25MM ROUND HD. REPORT SOURCE: FOREIGN- FRANCE. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00065.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G3, G6, H1, H2, H3, H4, H6, H10 CYCLOP SYNDROME IS CAUSED BY A SCAR TISSUE NODULE ADJACENT TO THE TIBIAL TUNNEL OF THE ANTERIOR CRUCIATE LIGAMENT GRAFT AFTER SURGERY. AS THE SCAR TISSUE BUILDS AROUND THE GRAFT AND ZIMMER BIOMET'S IMPLANTS WERE DIRECTLY CORRELATED WITH THE SCREWS, THERE ARE NO ALLEGATIONS AGAINST THE DEVICE AND ALL IMPLANTS REMAIN IN PLACE. HENCE, THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR FIBROSIS RESECTION THREE MONTHS POST IMPLANTATION DUE TO CYCLOPS SYNDROME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333783 GENTLE THREAD 9X30MM FULL THRD FASTENER, FIXATION HWC ZIMMER BIOMET, INC. N/A 490880 00880304006676

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Unknown Required Intervention