BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM MADE DEVICE POTAS PM-TMJ & MODEL

    MDR report key: 7361958 · Received March 22, 2018

    Report

    Report Number
    0001032347-2018-00141
    Event Type
    Injury
    Date Received
    March 22, 2018
    Date of Event
    February 23, 2018
    Report Date
    August 30, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE DESIGN. THE IMPLANT DID NOT FIT AS THE PART WAS NOT DESIGNED TO ACCOMMODATE ANKYLOSIS, WHICH WAS INDICATED ON THE DESIGN INPUT FORM. REVIEW OF THE DHR FOUND THE DESIGN INPUT FORM NOTATES THAT THE PATIENT DOES HAVE ANKYLOSIS AND THEREFORE THE FOSSA SHOULD HAVE BEEN FLATTENED OUT FURTHER. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO HUMAN ERROR ON THE PART OF THE INDIVIDUAL WHO DID NOT UPDATE THE DESIGN TO ACCOMMODATE ANKYLOSIS AND THE FACT THAT THERE IS NO DEFINED PROCEDURE FOR FOSSA COMPONENT DESIGN WHEN ANKYLOSIS IS PRESENT. THE DESIGN VENDOR REVISED THE WORK INSTRUCTION TO ADDRESS THIS. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN COUNTRY - (B)(6). PREMARKET IDENTIFICATION: THIS PRODUCT IS A CUSTOM IMPLANT THAT WAS MEANT FOR DISTRIBUTION IN (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET MANUFACTURES SIMILAR DEVICES THAT ARE CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P020016. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED "INTRAOPERATIVELY, THE FOSSA COMPONENTS (LEFT AND RIGHT) WERE NON-IMPLANTABLE DUE TO THE BONE TO BE RESECTED (STRAIGHT CUT EDGE) AND THE BULBAR (MOUNTAINOUS) STRUCTURE OF THE FOSSA IMPLANTS, ABRADING / CUTTING IMPLANTS ON BOTH SIDES INTRAOPERATIVELY REQUIRED IN ORDER TO IMPLANT TEP. A PRODUCT DEFECT IS SUSPECTED DUE TO A DESIGN ERROR, DELAY OF SURGERY 90 MIN, TOTAL SURGERY TIME (RESECTION AND ADAPTATION OF THE IMPLANT): 210 MIN, POSTOPERATIVE CT SCANS REQUESTED." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED, "THE PROBLEM WAS THAT THE FOSSA COULD NOT BE IMPLANTED AS IT WAS PRODUCED DUE TO THE RELIEF AT THE TOP OF THE IMPLANT. THE IMPLANT HAD TO BE ADAPTED WITH A SAW (FLAT THE TOP) SO THAT IT COULD FIT IN THE RIGHT POSITION. THE RELIEF WAS DESIGNED OUT OF THE PATIENT'S ANATOMY PERFECTLY, BUT DURING THE PROCEDURE (AFTER REMOVING THE BONE), THE FOSSA IMPLANT WIGGLES ON ITS POSITION AND DIDN¿T FIT IN THE RIGHT POSITION." NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206150 CUSTOM MADE DEVICE POTAS PM-TMJ & MODEL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 808890A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention