BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUFILL BONE SUBSTITUTE MATERIAL 3CC

    MDR report key: 11229305 · Received January 26, 2021

    Report

    Report Number
    3008812173-2021-00001
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    December 18, 2020
    Report Date
    January 27, 2022
    Manufacturer
    ZIMMER KNEE CREATIONS, INC.
    Product Code
    MQV
    PMA / PMN Number
    K190814
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H3; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; G3; G6; H1; H2. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1225112 MFR REPORT#: 0001225112-2022-00003.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1225112.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT DEVICES - ACCUFILL BONE SUBSTITUTE MATERIAL 3CC CATALOG #: 201.130, LOT #: 102222-0231. REPORT SOURCE - FOREIGN: (B)(6). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS USED AND REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 3008812173-2020-00025, 3008812173-2021-00001.

    Description of Event or Problem · 1

    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, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128229 ACCUFILL BONE SUBSTITUTE MATERIAL 3CC FILLER, BONE MQV ZIMMER KNEE CREATIONS, INC. N/A 102222-0005

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Hospitalization| R SEE H10 NARRATIVE