MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW MANIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Reaction (2414); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation tmj system left fossa component, small catalog # 24-6563 lot #: 648680b, biomet microfixation "2.4mm" system ht cross-drive screw catalog catalog #: 91-2710 lot #: ni, biomet microfixation tmj system cross drive fossa screw catalog #: 99-6577 lot #: ni, biomet microfixation tmj system cross drive fossa screw catalog #: 99-6579 lot #: ni.Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001032347-2018-00294, 0001032347-2018-00296, 0001032347-2018-00297, and 0001032347-2018-00298.

Event Description

It was reported via a letter from the patient that they no longer have the implants; the removal date is illegible.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00294-1, 0001032347-2018-00296-1, 0001032347-2018-00297-1, and 0001032347-2018-00298-1.

Event Description

Upon follow up with the surgeon, he stated the patient was explanted sometime in jan/feb; he was unable to recall the exact date.He had done an exploratory surgery once before and cleaned and irrigated the joint and he had noticed some sort of biofilm/pus and then he explanted the device this year and the patient functions well without it.They are considering a custom from tmj concepts, but the patient is well without a joint it seems.The surgeon said the device didn¿t fail, but that the patient just had some sort of reaction to it, he was unable to confirm if it was an allergic reaction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The surgeon confirmed that the products were explanted, therefore the complaint is confirmed.No product was returned and no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.It was not clear what caused the patient's reaction, therefore the most likely underlying cause of this complaint cannot be determined.The instructions for use (ifu) for this product warns of the potential for complications.It states in the section titled adverse events: infection (systemic or superficial).The ifu also states in the section titled patient counseling information: discussion of the following points is recommended prior to surgery.The importance of prompt medical attention if they experience unusual swelling in the area of the implant.The risks associated with a total tmj system (see warnings and adverse events).Post-operative pain relief and return of function varies from patient to patient.Device history record (dhr) was reviewed for the tmj components and no discrepancies relevant to the reported event were found.Device history record (dhr) review was unable to be performed for the screws as the lot number of the devices involved in the event is unknown.There are no indications of manufacturing defects.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00294-2, 0001032347-2018-00296-2, 0001032347-2018-00297-2, and 0001032347-2018-00298-2.

Event Description

This report is being submitted to document the completion of the investigation.

• Brand Name: TMJ SYSTEM LEFT NARROW MANIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7538848
• MDR Text Key: 109099805
• Report Number: 0001032347-2018-00295
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 589730A
• Other Device ID Number: (01)00841036011871
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention