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

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Particulates (1451)
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product - biomet microfixation unknown mandible screws.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: 0001032347-2019-00201, 0001032347-2019-00204 & 0001032347-2019-00206.
Event or Problem 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.
Additional 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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT, 45 MM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8482535
• Report Number: 0001032347-2019-00205
• Device Sequence Number: 13884075
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2002
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 014890
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention