BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT FOSSA

    MDR report key: 10944341 · Received December 4, 2020

    Report

    Report Number
    0001032347-2020-00597
    Event Type
    Injury
    Date Received
    December 4, 2020
    Date of Event
    November 19, 2020
    Report Date
    August 18, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D1; D4; G3; G4; G6; H1; H2; H3; H4; H6. D4: STERILE DATE - UNKNOWN. H4: MANUFACTURING DATE - UNKNOWN. PRODUCT ID IS BEING UPDATED TO UNKNOWN PART AND LOT NUMBERS, AS THE ORIGINALLY REPORTED PRODUCT ID WAS INCORRECT. THE INVESTIGATION IS STILL IN PROCESS. IF ANY FURTHER INFORMATION 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 RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE, AS ONLY THE MANDIBULAR COMPONENT WAS REVISED. THE INITIAL REPORT SHOULD BE VOIDED. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2020-00596, 0001032347-2020-00598, 0001032347-2020-00599. MEDICAL PRODUCTS: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 50MM / 9 HOLE, PART# 24-6550, LOT# 851360. TMJ SYSTEM RIGHT FOSSA COMPONENT, MEDIUM, PART# 24-6560-INT, LOT# 934560. TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 55MM / 12 HOLE, PART# 24-6556, LOT# 790490. TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL, PART# 24-6563-INT, LOT# 934590. UNKNOWN SCREWS, PART# NI, LOT# NI. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. FOREIGN REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WILL UNDERGO A REVISION AND REPLACEMENT OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE DUE TO DISPLACEMENT. THE MANDIBLE COMPONENT IS DISPLACED LATERALLY OUT OF THE FOSSA COMPONENT. THE DEVICES WILL BE REPLACED WITH A CUSTOM IMPLANT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408701 UNKNOWN RIGHT FOSSA JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A UNKNOWN

    Patients

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