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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: biomet microfixation "2.4mm" system ht cross-drive screw, 2.7x10mm catalog #: 91-2710 lot #: ni, biomet microfixation "2.4mm" system ht cross-drive screw, 2.7x12mm catalog #: 91-2712 lot #: ni.Therapy date: (b)(6) 2018.Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was discarded.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: 0001032347-2018-00737 and 0001032347-2018-00738.

Event Description

It was reported there was a tmj revision, no reason was provided.The patient had right side implants only.The right fossa component was not explanted.The right mandible was replaced with a new biomet mandibular implant.The surgeon also implanted a left fossa and left mandible during this revision.Attempts have been made and no further information has been provided.

Manufacturer Narrative

These products were removed 20 aug 2018; therefore the complaint is considered confirmed.More than three attempts were made to gather additional information including the failure mode and reason for the revision.However, this information was not provided.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, scans, or physician reports being provided.Based on the information and materials provided, it is unclear if there was an allegation made against the implants to function as intended or if they were removed due to patient condition.The non-conformance report was reviewed for the mandible component and no non-conformance was identified.Device history record (dhr) review was unable to be performed for the screws as the lot numbers of the devices involved in the event are unknown.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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00737-1 and 0001032347-2018-00738-1.

Event Description

This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8033399
• MDR Text Key: 125964984
• Report Number: 0001032347-2018-00736
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-6545
• Device Lot Number: 372390A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 17 YR