BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 6828428 · Received August 29, 2017

    Report

    Report Number
    0001032347-2017-00700
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 29, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THE REVISION WAS NOT PROVIDED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE PART AND LOT NUMBERS ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER: BECAUSE IT IS UNKNOWN WHICH SIDE WAS REVISED, BELOW ARE A LIST OF POSSIBLE DEVICES: POSSIBLE TMJ- DEVICE PRODUCT CODE: LZD, PMA/510(K) NUMBER: P020016. TMJ PART NUMBERS: 01-6546, LOT 151500A, MANUFACTURING DATE: 01/01/2010, IMPLANTED (B)(6) 2010. THE 24-6563, LOT 151800A, MANUFACTURING DATE: 12/01/2009, IMPLANTED (B)(6) 2010. THE 24-6545, LOT 831500D, MANUFACTURING DATE: 06/01/2009, IMPLANTED (B)(6) 2009. THE 24-6562, LOT 797630, MANUFACTURING DATE: 04/01/2009, IMPLANTED (B)(6) 2009. POSSIBLE SCREWS- LOT NUMBERS UNKNOWN DEVICE PRODUCT CODE: HWC, PMA/510(K) NUMBER: K113512, PART NUMBERS: 91-2710, 91-2712, 99-9950. DEVICE PRODUCT CODE: JEY, PMA/510(K) NUMBER: K910038, PART NUMBERS: 99-6577, 99-6587.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2017 THAT THE PATIENT'S TMJ PROSTHESIS REMOVAL WOULD BE PERFORMED ON (B)(6) 2017. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 1

    MORE INFORMATION WAS PROVIDED: THE REVISION WAS DUE TO THE PATIENT'S ANATOMY; SHE DEVELOPED ANKYLOSIS. THERE WAS NO ISSUE WITH THE PRODUCT. ONLY ONE SIDE WAS REVISED, HOWEVER IT IS UNKNOWN WHICH SIDE. THE IMPLANTS WERE REPLACED WITH NON-ZIMMER BIOMET PRODUCTS BASED ON THE PATIENT'S ANATOMY. THE REVISION WAS SUCCESSFUL; THE PATIENT WAS RECOVERING NICELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608946 WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R