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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event, explant date, and therapy date: the patient states her implants were explanted in (b)(6) 2017, the day is unknown.Concomitant medical products: biomet microfixation tmj right standard mandibular component catalog #: 24-6555, lot #: 578300b, biomet microfixation cross drive fossa screw catalog #: 99-6577, biomet microfixation ht cross-drive screw catalog #: 91-2710, therapy date: (b)(6) 2017.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: 0001032347-2018-00143, 0001032347-2018-001445, and 0001032347-2018-00146.

Event Description

It was reported by the patient her right implants were removed due to an infection.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The patient reported that these parts were removed in a revision; therefore the complaint is considered confirmed.No product was returned and no functional tests or inspections could be performed.No x-rays, scans, pictures, or physicians reports were provided.No additional details could be gathered.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The instructions for use (ifu) for this product has the following information in the section titled adverse events adverse events that may occur following placement of the total tmj replacement system are listed below: removal of components(s) including, but not limited to the following: implant changes caused by loading and/or wear.Degenerative changes within the joint surfaces from disease or previous implants.Implant materials producing particles or corroding.Infection (systemic or superficial).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: 0001032347-2018-00143-1, 0001032347-2018-001445-1, and 0001032347-2018-00146-1.

• 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
• MDR Report Key: 7370426
• MDR Text Key: 103465111
• Report Number: 0001032347-2018-00144
• 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
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/29/2021
• Device Model Number: N/A
• Device Catalogue Number: 24-6562
• Device Lot Number: 697960B
• Other Device ID Number: (01)00841036036560
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR