BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMPL F&A 3CC END 15GAX60MM

    MDR report key: 14621443 · Received June 7, 2022

    Report

    Report Number
    3008812173-2022-00001
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    October 26, 2017
    Report Date
    June 7, 2022
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    OJH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. PATIENT HAD AVN PRIOR TO THE INJECTION OF ACCUFILL AND EXTENSIVE COMORBIDITIES. ADDITIONAL CONTRIBUTING FACTORS ARE HISTORY OF POSITIVE DRUG TEST FOR COCAINE, OPIATES, AND OXYCODONE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE PATIENT'S REPORTED PAIN AND AMBULATORY ISSUES. 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. DATE REC'D BY MFR : THIS EVENT WAS PREVIOUSLY REPORTED INCORRECTLY UNDER WRONG MFR 0001225112-2020-00005 WITH IN 30 DAYS FOR INITIAL NOTIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY PATIENT'S LEGAL COUNSEL THAT THE PATIENT CLAIMS TO HAVE SPRAINED THEIR ANKLE AND RECEIVED A SERIES OF THREE (3) STEROID INJECTIONS AFTER THE SPRAIN OCCURRED. APPROXIMATELY TWO (2) MONTHS AFTER THE SPRAIN, THE PATIENT UNDERWENT A LEFT ANKLE SURGICAL PROCEDURE WHICH INCLUDED THE INJECTION OF ACCUFILL BSM. LEGAL CLAIM STATES PATIENT'S ANKLE DID NOT IMPROVE AFTER THE PROCEDURE AND CONTINUES TO SUFFER FROM PAIN, AMBULATORY ISSUES, AND POSSIBLE LEG AMPUTATION. PATIENT IS CURRENTLY USING AN EXOSYM BRACE AS WELL AS EITHER CRUTCHES OR A WHEELCHAIR SINCE THE IMPLANTATION. NO REVISION HAS BEEN REPORTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577785 CMPL F&A 3CC END 15GAX60MM INJECTION, BSM, BIOLOGICS OJH ZIMMER KNEE CREATIONS, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Other