MAUDE Adverse Event Report: BIOMET MICROFIXATION 45MM RT STANDARD MANDIBULAR; TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS

Catalog Number	24-6545
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: tmj med rtfossa comp cat# 24-6560 lot# 7951900.2.7x8mm ht x-drive screw cat# 91-2708 lot# 325450.2.7x10mm ht x-drive screw cat# 91-2710 lot# 398050.2.7x12mm ht x-drive screw cat# 91-2712 lot# 448720.Report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2021-00517, 0001032347-2021-00519, 0001032347-2021-00520, 0001032347-2021-00521.
Event or Problem Description
It was reported that the fossa prosthesis and mandibular component never fixed to the desired trajectory upon implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The 45mm rt standard mandibular (item# 24-6545, lot# 829250c) was returned for investigation.The mandible component was returned in good condition.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.It is alleged that the devices were implanted incorrectly, however, without medical records 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 or Problem Description
No further event information is available at the time of this report.

• Brand Name: 45MM RT STANDARD MANDIBULAR
• Common Device Name: TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12770318
• Report Number: 0001032347-2021-00518
• Device Sequence Number: 3119378
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: (01)00841036036430(17)230717(10)829250
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2023
• Device Catalogue Number: 24-6545
• Device Lot Number: 829250C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 03/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown