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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation tmj system right fossa component, small catalog #: 24-6562 lot #: 387730a, biomet microfixation tmj system left fossa component, small catalog #: 24-6563 lot #: 405160b, biomet microfixation tmj system right standard offset mandibular component catalog #: 24-6650 lot #: 405370a, biomet microfixation "2.4 mm" system ht cross-drive screw catalog #: 91-2710 lot #: ni, biomet microfixation "2.4 mm" system ht cross-drive screw catalog #: 91-2712 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, biomet microfixation "2.7 mm" system emergency cross drive screw catalog #: 99-9950 lot #: ni.Therapy date: (b)(6) 2018.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: 0001032347-2018-00251 through 0001032347-2018-00259.

Event Description

It was reported via the receipt of tmj tracking cards that a revision occurred.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.These parts were removed and replaced in a revision; therefore, the complaint is confirmed.There was no reason for the revision reported, and no additional information was provided to determine a specific failure mode.The manufacturing history was reviewed and no discrepancies were found.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00251-1, 0001032347-2018-00253-1, 0001032347-2018-00254-1, 0001032347-2018-00255-1, 0001032347-2018-00256-1, 0001032347-2018-00257-1, 0001032347-2018-00258-1, and 0001032347-2018-00259-1.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7495816
• MDR Text Key: 107644410
• Report Number: 0001032347-2018-00252
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 02/01/2015
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: 405420B
• Other Device ID Number: (01)00841036060329
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention