BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLE THREAD 8X25MM FULL THRD

    MDR report key: 15068041 · Received July 20, 2022

    Report

    Report Number
    0001825034-2022-01671
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    June 5, 2009
    Report Date
    August 31, 2022
    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). (DOB): 1969. CONCOMITANT MEDICAL PRODUCT: CATALOG #: 905608, GENTLE THREAD 9X30MM FULL THRD, LOT # UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FRANCE.PROCEDURAL RELATED COMPLICATIONS ARE INFLUENCED BY THE TYPE OF SURGERY, PATIENTS PRE-EXISTING COMORBID STATE, AND PERIOPERATIVE MANAGEMENT. DEEP VEIN THROMBOSIS, OR DVT, OCCURS WHEN A BLOOD CLOT FORMS IN ONE OF THE DEEP VEINS OF THE BODY. THIS CAN HAPPEN IF A VEIN BECOMES DAMAGED OR IF THE BLOOD FLOW WITHIN A VEIN SLOWS DOWN OR STOPS. ORTHOPEDIC PATIENTS ARE TYPICALLY PLACED ON MEDICATION POST-OPERATIVELY FOR A PERIOD OF TIME TO PREVENT THE DEVELOPMENT OF DVT/BLOOD CLOT. EVEN WITH THE ADMINISTRATION OF PREVENTIVE MEDICATION, DVT/BLOOD CLOTS CAN STILL DEVELOP. AS THE COMPLAINT INDICATED A POST-OPERATIVE COMPLICATION DEVELOPED AND MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE COMPLICATION. THE ROOT CAUSE WAS TRACED TO NON-DEVICE RELATED FACTORS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A STUDY THAT A PATIENT HAD INITIAL ACL REPAIR PERFORMED APPROXIMATELY 13 YEARS AGO. SUBSEQUENTLY, THE PATIENT DEVELOPED A DVT ABOUT 2 MONTHS AFTER THEIR INITIAL SURGERY REQUIRING MEDICAL INTERVENTION. THE DVT ULTIMATELY RESOLVED AND THE PATIENT COMPLETED THE STUDY WITH NO FURTHER COMPLICATIONS AND ON FOLLOW-UP HAS RETURNED TO A SUPERIOR LEVEL OF PHYSICAL ACTIVITY.

    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
    980860 GENTLE THREAD 8X25MM FULL THRD PROSTHESIS SPORTS MED HWC ZIMMER BIOMET, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention| H