MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 45MM / 6 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Information (3190); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).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: 0001032347-2020-00451, 0001032347-2020-00452, 0001032347-2020-00453 explantation date is planned for (b)(6) 2020.Concomitant medical devices ¿ medical products: tmj system right narrow mandibular component 45mm / 6 hole, part# 01-6545, lot# 747521; tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 747530; tmj system right investigative fossa, medium, part# 01-6560, lot# 095610; tmj system left investigative fossa, medium, part# 01-6561, lot# 095620; unknown screws, part# ni, lot# ni.
Event or Problem Description
It is reported the patient will undergo a revision to replace bilateral temporomandibular joint implants with a custom device sixteen (16) years following implantation due to an unknown reason.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
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.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
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 for all other devices.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 45MM / 6 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10566319
• Report Number: 0001032347-2020-00450
• Device Sequence Number: 2842921
• Product Code: LZD
• UDI-Device Identifier: 00841036011857
• UDI-Public: 00841036011857
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2021

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: Health Professional
• Device Expiration Date: 02/25/2004
• Device Model Number: N/A
• Device Catalogue Number: 01-6545
• Device Lot Number: 747521
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 07/15/2021; 08/18/2021
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 07/19/2021; 09/09/2021
• 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: Hospitalization; Required Intervention