MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 45MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Loss of Range of Motion (2032); Deformity/ Disfigurement (2360)
Date of Event	01/27/2022
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00180, 0001032347-2021-00181, 0001032347-2021-00182.Medical products: tmj system right fossa component, small, part# 24-6562, lot# 564610b.Tmj system left fossa component, small, part# 24-6563, lot# 578080a.Tmj system right standard offset mandibular component 45mm / 7 hole, part# 24-6645, lot# 468670a.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni, qty: 8.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni, qty: 1.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni, qty: 8.Occupation ¿ patient.
Event or Problem Description
It is reported the patient will undergo a revision 6 years following implantation of bilateral temporomandibular joint implants due to pain, limited mouth opening, and loss of occlusion.The patient has experienced increasing and debilitating pain, and has a pronounced overbite.The surgeon reported to the patient that there is bone growth around the implants.The patient will undergo a revision with custom tmj implants, and possibly undergo orthognathic surgery at the same time.It was reported that no further information is available.
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 count not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Ct scans were provided and were reviewed by clinical research principal engineer who stated that the scan show a biomet condyle implant bilaterally in place, fixated with 4 screws each side, apparently well positioned.The fossa implants cannot be appreciated due to radiolucency properties of the polymer material.However, 4 fixation screws are visible in each side corresponding with the fossa implant.It appears this patient would have benefited from an offset condylar prosthesis, instead of the regular one implanted.In my opinion, the condylar heads are in close contact with the lateral aspect of the articulating surface creating a mechanical malfunction of the joint that explains the limitation in mouth opening, the malocclusion and the increasing pain reported in this case.I do not see evidence of bone formation that can mechanically interfere with the proper function of the joints.However, there is a possibility for fibrocartilage growth, not possible to be appreciated in these images.These prostheses appear to have failed, likely from fibrocartilage growth acting as a mechanical interference between the condylar head and the articulating surface.There is also a possibility of failure related to an improper selection of the best fit of the implant based on the individual patient anatomy.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
It was initially reported the patient will undergo a revision six (6) years following implantation of bilateral temporomandibular joint implants due to pain, limited mouth opening, and loss of occlusion.The patient has experienced increasing and debilitating pain, and has a pronounced overbite.The surgeon reported to the patient that there is bone growth around the implants.The patient will undergo a revision with custom tmj implants, and possibly undergo orthognathic surgery at the same time.It was further reported that the patient underwent a revision procedure approximately seven (7) years post-implantation.All components were removed and replaced with competitor products.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated:b2, b3, b5, d6b, g1-2, g3, h2, and h6.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: b5, b7, e1, e2, e3, g3, h1, and h2.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 initially reported the patient will undergo a revision six (6) years following implantation of bilateral temporomandibular joint implants due to pain, limited mouth opening, and loss of occlusion.The patient has experienced increasing and debilitating pain and has a pronounced overbite.The surgeon reported to the patient that there is bone growth around the implants.The patient will undergo a revision with custom tmj implants, and possibly undergo orthognathic surgery at the same time.It was further reported that the patient was experiencing pain and unknown complications approximately 2 to 3 years post-implantation and received braces for the second time due to alleged failure of implants.Subsequently, the patient underwent a revision procedure approximately seven (7) years post-implantation.All components were removed and replaced with competitor products.
Event or Problem Description
No further event information 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: d4; h1; h2; h4; h6; h11.Root cause remains unchanged; a definitive root cause cannot be determined.

• Brand Name: TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 45MM / 7 HOLE
• 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: 11609310
• Report Number: 0001032347-2021-00183
• Device Sequence Number: 19807710
• Product Code: LZD
• UDI-Device Identifier: 00841036081560
• UDI-Public: (01)00841036081560(17)190818(10)546290B
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/02/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/27/2022
• Device Model Number: N/A
• Device Catalogue Number: 24-6646
• Device Lot Number: 546290B
• 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: 03/10/2021
• Supplement Date Received by Manufacturer: 11/08/2021; 01/09/2026; 02/11/2026; 05/05/2026
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 11/11/2021; 02/05/2026; 03/10/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female