BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M. H. JENSEN RIGHT PM-TMJ & MODEL

    MDR report key: 8134030 · Received December 5, 2018

    Report

    Report Number
    0001032347-2018-00837
    Event Type
    Injury
    Date Received
    December 5, 2018
    Report Date
    April 19, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. A TMJ-PM REQUEST WAS RECEIVED INDICATING THAT THESE IMPLANTS WILL BE REMOVED AND REPLACED IN A REVISION. A REVIEW OF THE PROVIDED TMJ-PM DESIGN INPUT FORM INDICATED THAT THE PATIENT ALREADY HAS A PATIENT MATCHED IMPLANT IN PLACE. THE DISTRIBUTOR PROVIDED IN A FOLLOW-UP CORRESPONDENCE THAT THE SURGEON DID NOT INDICATE THAT THE PRODUCT HAS MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED AND THE REASON FOR THE REVISION WAS "NEW BONE FORMATION". A REVIEW OF THE PROVIDED PREOPERATIVE PATIENT SCANS DOES NOT SHOW ANY EVIDENCE SUGGESTING THAT THE PATIENT MATCHED IMPLANTS THAT WERE IN PLACE HAS MALFUNCTIONED OR FAILED TO PERFORM AS INTENDED. SEVERAL PARTS WERE RETURNED FOR EVALUATION IN BIOHAZARDOUS CONDITION. THEY WERE EVALUATED THROUGH THE BAG AND WERE DETERMINED TO BE THE RIGHT MANDIBLE COMPONENT, RIGHT FOSSA COMPONENT AND A DRILLING GUIDE. THE MANDIBLE COMPONENT HAD WHITE FOREIGN MATERIAL LIKELY TO BE BONE TISSUE. THESE PARTS WERE REMOVED IN A REVISION; THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS IT WAS INDICATED THAT THERE WAS NO ALLEGED MALFUNCTION OF THE IMPLANTS. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO "NEW BONE FORMATION"/PATIENT CONDITION. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). EXPLANTED DATE: A REVISION IS SCHEDULED FOR (B)(6) 2019. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). PMA/510(K) NUMBER: THIS PRODUCT IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS BIOMET MICROFIXATION MANUFACTURES A SIMILAR DEVICE THAT IS 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 IS CURRENTLY IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WILL BE PERFORMED DUE TO NEW BONE FORMATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972656 M. H. JENSEN RIGHT PM-TMJ & MODEL PATIENT MATCHED TEMPOROMANDIBULAR JOINT IMPLANT LZD BIOMET MICROFIXATION N/A 244270A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R BIOMET MICROFIXATION UNK SCREW CATALOG #NI LOT #NI