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

Model Number	N/A
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling (2091); Discomfort (2330); No Code Available (3191)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.It is unknown at this time if the device will be returned for evaluation.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: 0001032347-2019-00461, 0001032347-2019-00462.Medical products: tmj system left fossa component, small; part# 24-6563, lot# 166470b, tmj system left narrow mandibular component, part# 01-6551, lot# 830930a, unknown screws, part# unk, lot# unk.Occupation: patient.
Event or Problem Description
It was reported a patient underwent a revision to remove temporomandibular implants on the left side.The patient reported the implant was removed because it was causing issues but no further information is available.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
This follow-up report is being submitted to relay additional information.It was reported the patient underwent a revision due to pain, discomfort, swelling and possible infection.The explanted devices were replaced with a joint built with a bone from the patient¿s arm.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.These implants were removed in a revision: therefore, the complaint is considered confirmed.It was reported that the implants were removed due to swelling and possible infection.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, pathology results, or physician's reports were provided.Based on the implant and explant date, the implants have been in place for >10 years prior to explantation and are therefore most likely not the cause of the swelling and potential infection as it occurred >1 year post-operatively.Dr.Berg, medical specialist in infectious diseases provides in his paper, overall, it is most likely that the patient would exhibit signs and symptoms of infection within the first year of implantation if it is implant related.The etiology of late infections is most likely hematogenous spread or direct inoculation from a contiguous structure.It is most likely after a year of implantation that the cause of infection is not implant related.The patient complained of numbness but there was no evidence provided that this was related to the devices that are in place.The non-conformance database (tipqa) was reviewed for the mandible component, no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving numbness, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving pain, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding infection, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the complaint could not be determined.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.The following fields were updated: date of this report, describe event or problem, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, method code, results code, conclusions code, additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9198693
• Report Number: 0001032347-2019-00462
• Device Sequence Number: 16255605
• Product Code: LZD
• UDI-Device Identifier: 00841036060428
• UDI-Public: 00841036060428
• 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: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2020

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 Model Number: N/A
• Device Catalogue Number: 01-6551
• Device Lot Number: 830930A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 01/03/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/05/2019; 01/23/2020
• 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: Required Intervention
• Patient Age: 46 YR