BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFILL BSM 3CC

    MDR report key: 10762151 · Received October 30, 2020

    Report

    Report Number
    0001225112-2020-00003
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    August 30, 2017
    Report Date
    March 11, 2021
    Manufacturer
    ETEX CORPORATION
    Product Code
    MQV
    PMA / PMN Number
    K190814
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D4: LOT NUMBER WAS CORRECTED FROM 1017780220 TO 101778. THE SERIAL NUMBER IS (B)(6). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF PROVIDED MEDICAL RECORDS NOTED NO COMPLICATIONS DURING THE INITIAL PROCEDURE. CONTRIBUTION FACTORS: PREVIOUS NON-UNION FRACTURE FOR APPROXIMATELY 2 YEARS PRIOR TO SURGERY. THE PATIENT FAILED MULTIPLE CONSERVATIVE TREATMENTS INCLUDING IMMOBILIZATION, PT, AND ULTRASOUND BONE STIMULATION. THE PATIENT SHOWS NO REAL DEVIATION FROM THE NORMAL DEEP PATTERN THAT COULD EXPLAIN HER PAIN IN HER RIGHT FOOT. POSSIBLY THIS IS CUMULATIVE TRAUMA WHERE SHE HAD SUFFERED SOME TYPE OF PREVIOUS INJURIES THAT MIGHT HAVE LED TO A TRIGGER AND AN INCREASE IN PAIN IN THIS AREA. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ACCUPORT CANNULA ITEM# 308151; LOT# 36904. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 1

    IT WAS REPORTED PATIENT PARTICIPATED IN A CLINICAL STUDY SCP OUTCOMES IN THE FOOT/ANKLE, AND UNDERWENT THE SCP PROCEDURE APPROXIMATELY THREE (3) YEARS AND THREE (3) MONTHS AGO. BASELINE PAIN SCORE WAS 5/10 AND 6/10, 5/10, 8/10, 7/10 6/10 AND 5/10 AT 2 WEEKS, 6 WEEKS, 3 MONTHS, 6 MONTHS, 12 MONTHS AND 24 MONTHS RESPECTIVELY. PATIENT WAS PRESCRIBED PHYSICAL THERAPY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230128 ACCUFILL BSM 3CC BIOLOGICS, BONE SUBSTITUTE MQV ETEX CORPORATION NI 101778

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention