MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SM RT FOSSA COMP; JOINT, TEMPOROMANDIBULAR, IMPLANT

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); Numbness (2415); Sensitivity of Teeth (2427); Fluid Discharge (2686); Peripheral Nervous Injury (4414); Paresthesia (4421); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint cmp (b)(4).D10 ¿ medical products item #01-6546ti, lot #820310d; 45mm lft narrow ti mand, item #24-6563, lot #833550b; tmj sm lft fossa comp, item # ni, lot # ni; unknown tmj system right mandible.G2: consumer: patient the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It is reported that the patient had a bilateral tmj procedure.Subsequently, the patient is experiencing pain on both sides, the sensation of pins and needles along with numbness on the right side of the face and ear.The patient alleges that touching the right side of the face feels like someone is sticking a finger in the right-side ear.There is also numbness on some of the right cheek and right side of the lip.Patient have been dealing with extreme pain on the right side mostly but sometimes the left hurts too.If the patient chews on the right side, clear fluid leaks from the right ear.This also happens on the left side but not as much as the right side.The leaking of fluid from chewing has been going on for more than five years now.The patient also has limited range of motion that interferes with opening mouth and teeth brushing.The left side does not open as wide as the right side.Patient¿s sleep is also disturbed.The right side is too painful to sleep on, so if the patient accidentally turns on the right side they awake and have to reposition.The patient¿s overbite has gotten worse since the surgery too.The patient is working with pcp for pain management.Patient is seeking an oral surgeon who will accept the patient¿s insurance.No further intervention has been reported to date.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D10 ¿ medical products: item #01-6546ti, lot #820310d; 45mm lft narrow ti mand.Item #24-6563, lot #833550b; tmj sm lft fossa comp.Item # 01-6546ti, lot # 651540a; 45mm rt narrow mandible.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: single panorex image demonstrates a plate and screw fixation of the mandibular ramus with condyle arthroplasty.Suggestion of anterior subluxation of the right mandibular condyle with limited evaluation of the left tmj.No fracture.Postsurgical changes of the right articular tubercle with three screws seen, possibly partially withdrawn.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that 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 sections b4, b5, d1, d2, d4, g3, g4, g6, h2, h3, h4, h6, h10, h11.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b5, g3, h1, and h6.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
It was reported that the patient had a bilateral tmj procedure.Subsequently, the patient is experiencing pain on both sides, the sensation of pins and needles along with numbness on the right side of the face and ear.The patient alleges that touching the right side of the face feels like someone is sticking a finger in the right-side ear.There is also numbness on some of the right cheek and right side of the lip.Patient have been dealing with extreme pain on the right side mostly but sometimes the left hurts too.If the patient chews on the right side, clear fluid leaks from the right ear.This also happens on the left side but not as much as the right side.The leaking of fluid from chewing has been going on for more than five years now.The patient also has limited range of motion that interferes with opening mouth and teeth brushing.The left side does not open as wide as the right side.Patient¿s sleep is also disturbed.The right side is too painful to sleep on, so if the patient accidentally turns on the right side they awake and have to reposition.The patient¿s overbite has gotten worse since the surgery too.The patient is working with pcp for pain management.Patient is seeking an oral surgeon who will accept the patient¿s insurance.No further intervention has been reported to date.It was further reported that the patient is alleging experiencing swelling and unknown complications on an unknown side approximately seven (7) years post-implantation.The patient has had no further intervention to date.However, attempts are being made to obtain additional information.
Event or Problem Description
It was reported that the patient had a bilateral tmj procedure.Subsequently, the patient is experiencing pain on both sides, the sensation of pins and needles along with numbness on the right side of the face and ear.The patient alleges that touching the right side of the face feels like someone is sticking a finger in the right-side ear.There is also numbness on some of the right cheek and right side of the lip.Patient have been dealing with extreme pain on the right side mostly but sometimes the left hurts too.If the patient chews on the right side, clear fluid leaks from the right ear.This also happens on the left side but not as much as the right side.The leaking of fluid from chewing has been going on for more than five years now.The patient also has limited range of motion that interferes with opening mouth and teeth brushing.The left side does not open as wide as the right side.Patient¿s sleep is also disturbed.The right side is too painful to sleep on, so if the patient accidentally turns on the right side they awake and have to reposition.The patient¿s overbite has gotten worse since the surgery too.The patient is working with pcp for pain management.Patient is seeking an oral surgeon who will accept the patient¿s insurance.No further intervention has been reported to date.It was further reported that the patient is alleging experiencing swelling and that the previously listed symptoms have continued to worsen approximately seven (7) years post-implantation.The patient has also noted that she has lost control over her lips.Finally, the patient alleges that she has lost most of the top right ack tooth as well as the back two teeth which causes the patient pain and sensitivity.The patient has had no further intervention to date.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b5, b7, g3, h6, and h11.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b5; g3; h1; h2; h6; h11.Root cause remains unchanged.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
No further event information available at the time of this report.

• Brand Name: TMJ SM RT FOSSA COMP
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20476521
• Report Number: 0001032347-2024-00328
• Device Sequence Number: 15291858
• Product Code: LZD
• UDI-Device Identifier: 00841036036560
• UDI-Public: (01)00841036036560(17)230516(10)829080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/09/2026

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: 05/16/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6562
• Device Lot Number: 829080C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 08/12/2025; 09/11/2025; 02/09/2026
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 01/30/2025; 09/09/2025; 10/07/2025; 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2018
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown