BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAR PM-TMJ & MODEL

    MDR report key: 7881694 · Received September 17, 2018

    Report

    Report Number
    0001032347-2018-00619
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    August 30, 2018
    Report Date
    February 25, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF PATIENT SCANS. ONLY THE RIGHT MANDIBULAR COMPONENT OF TMJPM-0418 WAS RETURNED. THE EXACT IDENTITY OF THE SCREWS COULD NOT BE IDENTIFIED AS THE IMPLANTS WERE RETURNED IN A BIOHAZARDOUS STATE AND COULD NOT BE REMOVED FROM THE BAG FOR MEASUREMENT AND IDENTIFICATION PURPOSES. IT WAS REPORTED THESE PARTS WERE REMOVED IN A REVISION DUE TO PAIN AND LIMITED MOUTH OPENING. THE PATIENT PREVIOUSLY HAD THESE CUSTOM IMPLANTS PUT IN TO REPLACE STOCK TMJ PARTS. IT WAS REPORTED THAT DURING THE CURRENT REVISION, THE SURGEON FOUND THAT THE 'FOSSA HAD BONE GROWTH OVER IT AND OVAL NATURE OF SCREW HOLES INDICATED FOSSA HAD BEEN MOVING IN SITU. MANDIBLE POSITION WAS CONFIRMED AS BEING TOO FAR POSTERIOR. BOTH FOSSA AND MANDIBLE COMPONENTS REMOVED AND REPLACED WITH A COSTOCHONDRAL GRAFT TO MAINTAIN JAW FUNCTION. IT WAS ALSO FOUND THAT ON THE RIGHT SIDE THE CORONOID PROCESS HAD ANKYLOSED TO THE ZYGOMATIC ARCH AND WAS ALSO PREVENTING MOVEMENT'. EXPLANTED PRODUCT WAS RETURNED IN A BIOHAZARDOUS CONDITION. BONE FRAGMENTS AND PATIENT TISSUE WERE VISIBLE ON THE RETURNED IMPLANTS CONFIRMING THAT THESE PARTS WERE REMOVED IN A REVISION. ONE OF THE ELEVEN SCREWS THAT WERE RETURNED WAS STILL ENGAGED WITH THE MANDIBULAR IMPLANT WITH A FRAGMENT OF BONE STILL ATTACHED INDICATING THAT THE SCREW WAS PULLED OUT OF THE PATIENTS BONE RATHER THEN BACKED OUT CONVENTIONALLY. THE TWO MOST ANTERIOR SCREW HOLES OF THE RETURNED FOSSA IMPLANT APPEARED OBLONG BUT IT COULD NOT BE DETERMINED IF THIS WAS CAUSED BY MOVEMENT IN-SITU AS REPORTED OR BY THE EXTRACTION PROCESS. THE DESIGN VENDOR CONDUCTED AN INVESTIGATION INTO THE COMPLAINT; THEIR INVESTIGATION IS AS FOLLOWS: THIS SURGERY WAS PERFORMED IN 2015. TMJ DESIGNER HAD A WEB MEETING WITH SURGEON TO DISCUSS THE CASE ON (B)(6) 2018 BEFORE HE PLANNED ON GOING INTO SURGERY ON (B)(6) 2018 TO REVISE THE JOINTS. THE SURGEON WAS NOT THE ORIGINAL SURGEON FOR THIS PATIENT¿S CASE. ON (B)(6) 2018 THE DESIGN VENDOR RECEIVED NEW SCAN DATA WHICH WAS COMPARED TO THE ORIGINAL DESIGN. IT WAS DETERMINED THE MAIN ISSUE WAS A RIGHT MANDIBULAR IMPLANT THAT WAS NOT IMPLANTED AS THE DESIGNER AND ORIGINAL SURGEON PLANNED; IT WAS ROTATED POSTERIORLY AT THE ARTICULATING HEAD. WITH THIS POSITION AND THE STOCK FOSSA THAT WAS PREVIOUSLY IMPLANTED WITH AN ANTERIOR ROTATION, THE JOINT SEEMS TO BE DISLOCATING POSTERIORLY AND CAUSING THE PATIENT PAIN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE CUSTOM TMJ AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE NON-CONFORMANCE REPORT WAS REVIEWED FOR THE STOCK RIGHT FOSSA COMPONENT, NO NON-CONFORMANCE WAS IDENTIFIED FOR THIS PART AND LOT. DHR REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE PART NUMBERS AND LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO THE CUSTOM RIGHT MANDIBULAR IMPLANT WAS NOT IMPLANTED AS THE DESIGNER AND ORIGINAL SURGEON PLANNED. THE PATIENT ALSO HAD BONE GROWTH OVER THE FOSSA AND THE CORONOID PROCESS HAD ANKYLOSED TO THE ZYGOMATIC ARCH. THESE ARE PATIENT CONDITIONS THAT ALSO CONTRIBUTED TO THE IMPLANTS BEING REMOVED IN A REVISION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2018-00641-1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANT DATE: (B)(6) 2012. CONCOMITANT MEDICAL DEVICE: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT MEDIUM, CATALOG #: 24-6561, LOT #: "363990;" BIOMET MICROFIXATION FOSSA SCREW, CATALOG #: NI, LOT #: NI; BIOMET MICROFIXATION MANDIBLE SCREW, CATALOG #: NI, LOT #: NI. THERAPY DATE: (B)(6) 2018. 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 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: 0001032347-2018-00641.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION WAS PERFORMED DUE TO THE PATIENT HAVING A "SEVERELY LOCKED JAW," EXPERIENCING SEVERE PAIN AND LIMITED MOUTH OPENING OF ABOUT SIX MILLIMETERS. PATIENT HAD BILATERAL TMJ IMPLANTS WHICH WERE ORIGINALLY REVISED IN (B)(6) 2012 TO REPLACE EXISTING STOCK MANDIBLES WITH CUSTOM MANDIBLES. PATIENT PRESENTED TO (B)(6) HOSPITAL IN (B)(6) 2018 WITH SIGNIFICANT PAIN AND LIMITED MOUTH OPENING. SURGICAL TEAM FELT THE SEVERITY OF THE PROBLEM REQUIRED ADDRESSING URGENTLY. A WEB CALL WITH THE DESIGNERS SUGGESTED A COMBINATION OF ANTERIOR TILT OF THE FOSSA AND POSTERIOR TILT OF THE RIGHT MANDIBLE IN PARTICULAR WAS MOST LIKELY REASON FOR THE ISSUES. OPERATION WAS CARRIED OUT ON TO EXPLORE RIGHT SIDE OF JAW. FOSSA HAD BONE GROWTH OVER IT AND OVAL NATURE OF SCREW HOLES INDICATED FOSSA HAD BEEN MOVING IN SITU. MANDIBLE POSITION WAS CONFIRMED AS BEING TOO FAR POSTERIOR. BOTH FOSSA AND MANDIBLE COMPONENTS WERE REMOVED AND REPLACED WITH A COSTOCHONDRAL GRAFT TO MAINTAIN JAW FUNCTION. IT WAS ALSO FOUND THAT ON THE RIGHT SIDE THE CORONOID PROCESS HAD ANKYLOSED TO THE ZYGOMATIC ARCH AND WAS ALSO PREVENTING MOVEMENT. THIS WAS ALSO RELEASED AND PATIENT HAD A MOUTH OPENING OF THIRTY-EIGHT MILLIMETERS POST OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723736 LEAR PM-TMJ & MODEL PATIENT MATCHED TEMPOROMANDIBULAR JOINT IMPLANT LZD BIOMET MICROFIXATION N/A 394870A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R