MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM; PLATE, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Difficulty Chewing (2670)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).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: 0001032347-2020-00562, 0001032347-2020-00563, 0001032347-2020-00564, 0001032347-2020-00565, 0001032347-2020-00566, 0001032347-2020-00567.Medical products: tmj system right narrow mandibular component 50 mm / 7 hole, part# 01-6550, lot# 410290.Tmj system left narrow mandibular component 50mm / 7 hole, part# 01-6551, lot# 694760.Tmj system right fossa component, small, part# 24-6562, lot# 797600.Tmj system left fossa component, small, part# 24-6563, lot# 753770.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni.Occupation¿ patient.
Event or Problem Description
It was reported the patient is experiencing pain and difficulty chewing eleven (11) years following implantation of bilateral temporomandibular joint implants.The patient indicates that the pain is better than before the surgery but is still being experienced.The patient reports that their jaw has shifted so that their teeth do not touch, and as a result the patient cannot chew or tear meat.The patient has broken several teeth due to bruxism and their dentist believes the breakages are due to trauma from the initial surgery.The patient receives botox shots for burning or firing nerves that cause pain.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Revi lot identification is necessary for review of device history records, lot identification was not provided for the screws.The reported products were reviewed for compatibility with no issues noted.A definitive root cause cannot 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.This report is being submitted to update additional information in section b4, b5, g3, g6, h1, h2, h3, h6 and h10.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It has been further reported that the tmj patient reports that they are experiencing pain, pain in the ear, muscle tightness and that their jaw has shifted to where their teeth do not touch.Patient's jaw is locking and this is due to a calcium bone growth in her right joint of the device per a ct scan.Patient was told in order to resolve the issue a complete bi-lateral joint revision would be needed.In order to put off surgery, patient has gone to physical therapy to increase mobility and stretch inside of mouth.Patient is at 33 mm.Patient was referred back to her implant surgeon.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.There are no changes to the previous investigation outcomes.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.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 9MM
• Common Device Name: PLATE, BONE
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10791435
• Report Number: 0001032347-2020-00568
• Device Sequence Number: 19101122
• Product Code: JEY
• UDI-Device Identifier: 00841036057459
• UDI-Public: 00841036057459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2022

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: 99-6579
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 09/16/2021; 07/07/2022
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 09/30/2021; 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Female