MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 45MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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: 0001032347-2021-00081.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot# 531090a.Unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Initial reporter occupation ¿ patient.
Event or Problem Description
It was reported the patient underwent a revision a couple years ago for an unknown reason following implantation of temporomandibular joint implants on the left side six (6) years ago.The patient is uncertain if the device remains implanted.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00082, 0001032347-2021-00473, 0001032347-2021-00474, 0001032347-2021-00475.D10 ¿ medical products: tmj system left fossa component, small, part# 24-6563, lot 531090a.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot ni.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot ni.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.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 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.

• Brand Name: TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 45MM / 7 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11365042
• Report Number: 0001032347-2021-00082
• Device Sequence Number: 3335669
• Product Code: LZD
• UDI-Device Identifier: 00841036081560
• UDI-Public: (01)00841036081560(17)180621(10)461030
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• 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: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021

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: 06/21/2018
• Device Model Number: N/A
• Device Catalogue Number: 24-6646
• Device Lot Number: 461030A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 10/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention