MAUDE Adverse Event Report: BIOMET MICROFIXATION TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Health Effect - Clinical Codes	Swelling (2091); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Concomitant medical products: unknown biomet microfixation screws catalog #: ni, lot #: ni; biomet microfixation fossa catalog #: 01-6561, lot #: 120581.Therapy date unknown.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: 0001032347-2019-00238.
Event or Problem Description
It was reported that the surgeon is planning a revision due to an allergic reaction, facial swelling, and the presence of polyethylene particles.It was reported that the patient has had periodic facial swelling for the past year.The surgeon believes the patient needs to be revised due to wear of the fossa; that a custom implant is needed because there is not much zygomatic arch left for stock implant placement; and that the patient requires an all titanium implant as allergy testing came back as reactive.
Event or Problem Description
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.The parts were not returned for evaluation; therefore, no functional testing or inspections could be performed.The complaint is considered confirmed as allergy testing was reactive and an all titanium custom implant was requested.This indicates the most likely underlying cause of the complaint is patient condition.There are no indications of manufacturing defects.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.

• Brand Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8528277
• Report Number: 0001032347-2019-00239
• Device Sequence Number: 11233883
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• 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: 2000
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2004
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 747530
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 08/07/2019
• 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: Required Intervention