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

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Increased Sensitivity (2065); Limited Mobility Of The Implanted Joint (2671); No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00015, 0001032347-2020-00016, 0001032347-2020-00017, 0001032347-2020-00018.Medical products: tmj system right narrow mandibular component, part# 01-6550, lot# 541410c, tmj system right fossa component, small, part# 24-6562, lot# 561150a, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, traumaone system 2.0x7mm self-drilling imf screw, part# 91-5607, lot# unk, tmj system cross drive fossa screw, part# 99-6577, lot# unk.Occupation: patient.
Event or Problem Description
It was reported the patient may undergo a revision of temporomandibular joint implants on the right side at a later unspecified date due to an unknown reason.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following fields were updated: b4 date of this report b5 describe event or problem g4 date received by manufacturer g7 type of report h2 follow up type h6 patient code h6 device code h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.The patient reported pain, sensitivity, limited range of motion and device squeaking.The patient reported that imaging reveals some degree of separation with the implant and that different surgeons have recommended replacement of the temporomandibular joint prostheses with either a custom implant or a bone graft.No revision is planned at this time.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.The patient relocated and is looking for a new surgeon and the device remains implanted.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database 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) regarding pain, there is a complaint rate of 2.03%, 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 limited range of motion, there is a complaint rate of 0.70%, 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 squeaking or noises, there is a complaint rate of 1.01%, 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 dislocation, there is a complaint rate of 0.27%, which is no greater than the occurrence listed in the afmea.The most likely underlying cause 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9546783
• Report Number: 0001032347-2020-00014
• Device Sequence Number: 2461178
• Product Code: LZD
• UDI-Device Identifier: 00841036011895
• UDI-Public: 00841036011895
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2020

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 Expiration Date: 08/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 01-6550
• Device Lot Number: 541410C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/20/2020; 05/21/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/12/2020; 05/27/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention