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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
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.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00029, 0001032347-2020-00030, 0001032347-2020-00031.Concomitant medical products: tmj system right standard mandibular component, part# 24-6545, lot# 845380a.Tmj system left standard mandibular component, part# 24-6551, lot# 702950a.Tmj system right fossa component, small, part# 24-6562, lot# 864760b.Tmj system left fossa component, small, part# 24-6563, lot# 854360c.Unknown screws, part# unk, lot# unk.Initial reporter occupation - patient.
Event or Problem Description
It was reported the patient underwent a bilateral revision of temporomandibular joint implants.Attempts have been made and no further information has been provided.
Event or Problem Description
The patient reported that her implants were removed in a revision; however, her surgeon reports that no revision occurred and the devices remain implanted.There is no device malfunction, patient injury or revision within this file; therefore, there is no indication of a reportable event.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9564895
• Report Number: 0001032347-2020-00028
• Device Sequence Number: 2325782
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: 00841036036430
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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 Model Number: N/A
• Device Catalogue Number: 24-6545
• Device Lot Number: 845380A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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