MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN TMJ SYSTEM LEFT FOSSA COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint #: (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It is reported that the patient's condyle is outside the fossa component and that there only four (4) screws on the mandible.The patient is experiencing pain in the ear and face.There is a plan to revise and remove the joint at some time in the future, but no plan or date for the surgery has been established at this time.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10 ¿ medical products item # ni, lot #ni, unknown tmj system right fossa component, item # ni, lot # ni, unknown tmj system right mandible component, item # ni, lot # ni, unknown tmj system right fossa component.G2: foreign reporter: united kingdom.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The case was reviewed by 3d systems during the design process of a possible replacement patient matched tmj device.3ds provided images of the patient's anatomy from the surgeon as of april which confirmed the mandibular head is displaced and is not mating with the center of the fossa component.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00337, 0001032347-2022-00336, 0001032347-2022-00338.This report is being submitted to update additional information in section b4, b5, d1, d4, d9, d10, g3, g6, h2, h3, h6 and h10.

Event Description

No further event information is available at the time of this report.

• Brand Name: UNKNOWN TMJ SYSTEM LEFT FOSSA COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14698828
• MDR Text Key: 294120128
• Report Number: 0001032347-2022-00195
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-1787
• Device Lot Number: 766300A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other