MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT, 45 MM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Material Erosion (1214); Particulates (1451)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical product - biomet microfixation unknown mandible screws, catalog #: ni, lot#: ni.The investigation is in process.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: 0001032347-2019-00204, 0001032347-2019-00205 & 0001032347-2019-00206.

Event Description

It was reported that a revision is planned for the patient due to an allergic reaction and the presence of polyethylene particles.The patient has developed periodic facial swelling throughout the last year.A biopsy of the site showed polyethylene particles; no infection was found.The patient will have a revision due to wear of the fossa.Allergy testing came back as reactive; an all titanium implant is needed.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The parts were not returned for evaluation; therefore, no functional testing or inspections could be performed.However, the complaint is considered confirmed as tmjpm-2570 was requested for manufacture, and the most likely underlying cause of the complaint is patient condition.There are no indications of manufacturing defects.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.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT, 45 MM
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8482519
• MDR Text Key: 140899080
• Report Number: 0001032347-2019-00201
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036011857
• UDI-Public: 00841036011857
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2003
• Device Model Number: N/A
• Device Catalogue Number: 01-6545
• Device Lot Number: 261410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention