BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE THREAD 8X25MM FULL THRD

    MDR report key: 16228480 · Received January 23, 2023

    Report

    Report Number
    0001825034-2023-00116
    Event Type
    Injury
    Date Received
    January 23, 2023
    Date of Event
    October 25, 2010
    Report Date
    May 12, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    K982497
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED PER THE MEDICAL INVESTIGATION. HEMARTHROSIS IS A COLLECTION OF BLOOD THAT FORMS IN THE JOINT SPACE FOLLOWING A PROCEDURE IF THE SMALL VESSELS WERE NOT CAUTERIZED PRIOR TO CLOSURE. THE HEMARTHROSIS CAN BE ASSOCIATED WITH PAIN, SWELLING, SEROSANGUINOUS OR BLOODY DRAINAGE AFTER A RECENT SURGICAL PROCEDURE OR TRAUMA AND CAN PREDISPOSE THE PATIENT TO INFECTION. THE OCCURRENCE TYPICALLY RESOLVES ON ITS OWN, WITHOUT SURGICAL INTERVENTION, WHILE SOMETIMES AN EVACUATION OF THE FLUID COLLECTION IS REQUIRED THROUGH ASPIRATION OR SURGICAL EVACUATION. AS TIMEFRAMES OF ONSET DIFFER DUE TO INDIVIDUAL CONTRIBUTING FACTORS, A SPECIFIC TIMEFRAME OF EXPECTED OCCURRENCE CANNOT BE ESTABLISHED. THE ROOT CAUSE WAS FOUND TO BE NON-DEVICE RELATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: CATALOG #: 905608, GENTLE THREAD 9X30MM FULL THRD, LOT #: UNKNOWN. REPORT SOURCE: (B)(6). 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 REPORT: 0001825034-2023-00114.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN ADDITIONAL SURGERY UNDER ANESTHESIA TO EVACUATE THE HEMARTHROSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EFFUSION/SWELLING/EDEMA. POSTOPERATIVE HEMARTHROSIS NOT LINKED TO THE DEVICES IMPLANTED BUT TO THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407595 GENTLE THREAD 8X25MM FULL THRD SPORTS MED IMPLANT HWC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H| O