BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFILL BSM 3CC (CE)

    MDR report key: 13416704 · Received February 1, 2022

    Report

    Report Number
    0001225112-2022-00002
    Event Type
    Injury
    Date Received
    February 1, 2022
    Date of Event
    December 18, 2020
    Report Date
    January 27, 2022
    Manufacturer
    ETEX CORPORATION
    Product Code
    MQV
    PMA / PMN Number
    K190814
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001225112-2022-00003. FULL UDI - (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 201.130; LOT# 102222, ITEM# 331.100; LOT# KC05531, ITEM# 307.032; LOT# 40004, ITEM# 307.032; LOT# 39230. FOREIGN - EVENT OCCURRED IN (B)(6). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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

    IT IS REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN IMMEDIATELY FOLLOWING A SUBCHONDROPLASTY PROCEDURE UTILIZING AN ACCUFILL INJECTION. THE PAIN REQUIRED PROLONGED HOSPITALIZATION AND WAS TREATED WITH OXICODON, A PATIENT-CONTROLLED ANALGESIA (PCA) PUMP AND TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS). TO DATE, THE PATIENT'S PAIN HAS DECREASED, BUT CONTINUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496783 ACCUFILL BSM 3CC (CE) FILLER, BONE VOID, CALCIUM COMPOUND MQV ETEX CORPORATION NI 102222

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention| H