BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ALLOSYNC PURE DBM

    MDR report key: 20192428 · Received September 10, 2024

    Report

    Report Number
    MW5159481
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    November 12, 2023
    Report Date
    September 7, 2024
    Manufacturer
    ARTHREX, INC./ISOTIS ORTHOBIOLOGICS, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 I HAD A RECALLED EXACTECH GLENOID COMPONENT REMOVED THAT LEFT A LARGE DEFECT. MY DR. WENT AGAINST FDA AND OTHER ORTHOPEDIC SOCIETIES RECOMMENDATIONS AND INJECTED ARTHREX ALLOSYCH PURE DBM IN SAID DEFECT. I HAVE EXPERIENCED CRIPPLING PAIN SINCE THIS SURGERY AND AFTER FINALLY GETTING A DEEP BONE BIOPSY PREFORMED 10 MONTHS LATER I WAS DIAGNOSED WITH A SEVERE INFECTION OF THE SHOULDER. I AM CURRENTLY ON IV ANTIBIOTICS FOR AT LEAST THE NEXT 6 WEEKS AND FACING MULTIPLE FURTHER SURGERY AS A RESULT OF THIS INCOMPETENCE. FOR MONTHS FOLLOWING THE GRAFT SURGERY I BEGGED THE SURGEON TO PERFORM TESTS TO DIAGNOSE PROBLEM AND WAS REFUSED. SINCE THEN THERE HAS BEEN A COORDINATED EFFORT BY THE ORIGINAL DR AND OTHERS TO CONCEAL ANY INFORMATION ABOUT THE CONDITION OF THE GRAFT EVEN GOING SO FAR AS TO SAY I HAD A PRE-EXISTING INFECTION PRIOR TO PLACING THE GRAFT THAT NO SAMPLES TAKEN DURING ORIGINAL SURGERY PROVE. ARTHREX LITERATURE MAKES NO MENTION OF ITS PRODUCT BEING USED FOR THIS APPLICATION AND EVEN THIS AGENCY RECOMMENDS AGAINST IT AND IT WAS DONE ANYWAY. I'M ASKING ON BEHALF OF FUTURE PATIENTS THAT THIS UNFORTUNATE PRACTICE IS THOROUGHLY INVESTIGATED AND RESPONSIBLE PARTIES HELD ACCOUNTABLE BY ANY MEANS AT THIS AGENCIES DISPOSAL. I'M PLANNING TO FILE A MEDICAL BOARD COMPLAINT AS WELL AND IF I HAD THE MEANS I WOULD SUE THIS DOCTOR FOR THE MENTAL AND PHYSICAL PAIN I'VE ENDURED I'M BEGGING THIS AGENCY TO INVESTIGATE THIS AND ANY OTHER PATIENTS THIS DR. HAS HARMED WITH HIS OFF LABEL MEATBALL SURGERY I'M SURE I'M NOT THE ONLY ONE THAT'S BEEN HARMED BECAUSE HE BRAGGED HE DOES THIS SURGERY ALL THE TIME AND I'M THE ONLY ONE HE'S SEEN HAVE PROBLEMS WITH IT. THIS DOCTOR HAS GONE TO GREAT LENGTHS GASLIGHTING ME FOR HAVING MENTAL HEALTH ISSUES TO OTHER DOCTOR'S TO CONCEAL FACTS ABOUT THE CONDITION OF THE GRAFT. WHICH I ONLY RECENTLY LEARNED IS FRACTURED WITH LOOSE BONE FRAGMENTS FLOATING IN THE JOINT SPACE WITH SIGNIFICANT FIBROTIC TISSUE NOTED. THANK YOU FOR YOUR TIME AND CONSIDERATION IN INVESTIGATING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558405 ARTHREX ALLOSYNC PURE DBM FILLER, BONE VOID, CALCIUM COMPOUND MQV ARTHREX, INC./ISOTIS ORTHOBIOLOGICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other