MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN LEFT TMJ FOSSA COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient underwent a tmj procedure on an unknown date.Subsequently, the patient is scheduled to be revised on an unknown date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint cmp- (b)(4).D6: implant procedure date was (b)(6) 2020.D10 ¿ medical products: item # unknown, lot # unknown; unknown left tmj fossa component.Item # unknown, lot # unknown; unknown left tmj mandible component.Item # unknown, lot # unknown; unknown right tmj fossa component.Item # unknown, lot # unknown; unknown right tmj mandible component.G2: foreign source: germany.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00130, 0001032347-2023-00131, and 0001032347-2023-00132.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10; product information received clarifying fossa components of both sides are bulky.Complaint history review cannot be performed without product identification.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Additional information provided does not change the root cause of the previous investigation.The reported event cannot be confirmed with supplied information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

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: b4; b5; d2; g3; g6; h1; h2; h3; h6; h10.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental 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 follow-up report is being submitted to relay additional information.B3: issue discovered in september 2022.Revision took place in january 2023.D6b.Explanted in (b)(6) 2023.

Event Description

It was reported that a revision was performed due to the implants being too bulky causing the patient pain.

• Brand Name: UNKNOWN LEFT TMJ FOSSA COMPONENT
• 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: 16761615
• MDR Text Key: 313502026
• Report Number: 0001032347-2023-00129
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/27/2023; 07/10/2023; 08/10/2023
• Supplement Dates FDA Received: 05/26/2023; 08/09/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female
• Patient Race: White