MAUDE Adverse Event Report: BIOMET MICROFIXATION WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; 45MM LEFT NARROW MANDIBLE

Model Number	N/A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); Difficulty Chewing (4522)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of seven for the same event, reference 0001032347-2016-00714 through 0001032347-2016-00720.
Event or Problem Description
The patient reported her jaw freezes up now and then and there may be a revision surgery due to the issues she is experiencing.Multiple attempts were made, however no additional information was received and the revision was not confirmed.
Event or Problem Description
It was reported that the patient is experiencing pain on both sides of her jaw and she cannot chew.No additional information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.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 available at the time of this report.

• Brand Name: WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Common Device Name: 45MM LEFT NARROW MANDIBLE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 6136534
• Report Number: 0001032347-2016-00715
• Device Sequence Number: 787583
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: (01)00841036011871(17)20190804(10)541380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PP020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Device Unattended
• Device Expiration Date: 08/04/2019
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 541380C
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 03/15/2023; 06/01/2023
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 04/14/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female