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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Ossification (1428); Headache (1880); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Ankylosis (4527); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  Injury  

Event Description

It is reported that the patient underwent a revision of the right fossa implant due to unknown reasons.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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.

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.Review of the device history records identified no deviations or anomalies during manufacturing.An adequate complaint history review cannot be performed as the complication, failure mode, and/or harm experienced by the user is unknown.One additional previous report from this patient was identified for this item/lot combination.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, h2, h3, h6 and h10.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; g3; g6; h1; h2; h3; h6 medical records were provided and reviewed by a health care professional.Review of the available records identified the following: contributing factors of the event included a previous revision, juvenile rheumatoid arthritis (jra), dysautonomia, bruxism, and non-compliance with post-op exercises.Following the previous revision, the patient reported pain, decreased hearing, non-compliance with the suggested therabite exercises, severe limitation of rom, and received botox injections to muscles of mastication.Planned right tmj revision, removal of heterotopic bone, bilateral coronoidectomy, autogenous fat grafting.Ct report stated on the left side, revision of left total tmj, hardware in expected position, removal of heterotopic ossification along the medial aspect of mandibular ramus noted, no lucency, noted nonactue appearing osteotomy/fracture of the coronoid process with incomplete healing, no soft tissue swelling or fluid collection.Ct report stated on the right side, revision of right total tmj with removal of 2 screws from the zyogmatic arch and bone to the medial right ramus, noted interval osteotomy/fracture of coronoid process, hardware normally aligned, no soft tissue swelling or fluid collection.The pre-op diagnosis included heterotopic bone formation, trismus, intracapsular ankylosis, difficulty chewing, keloid scar in the left preauricular region and left temporal hairline.The root cause of the previous investigation remains unchanged - cannot be determined.If any further information 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 Description

No further event information available at the time of this report.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, b7, d6b, g3, g6, h2, h6 and h10.

Event Description

It was reported that the initial procedure was a bilateral temporomandibular joint replacement.The patient underwent a revision due to decrease mouth opening, pain, heterotopic bone formation, and stiffness.During the surgery keloid scar tissue was noted on the right.The right fossa and screws were exchanged.Harvested fat was packed to wounds without complications.Bilateral masseter muscle was released to assist maximum incisal opening.

• Brand Name: TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
• Type of Device: 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: 15093202
• MDR Text Key: 296475688
• Report Number: 0001032347-2022-00227
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036560
• UDI-Public: (01)00841036036560(17)201228(10)651390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 24-6562
• Device Lot Number: 651390A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/25/2022
• Supplement Dates Manufacturer Received: 09/16/2022; 11/01/2022; 12/05/2022
• Supplement Dates FDA Received: 10/04/2022; 11/30/2022; 12/14/2022
• Date Device Manufactured: 12/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Race: Black Or African American