MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Granuloma (1876); Pain (1994); Reaction (2414); Fibrosis (3167)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a left temporomandibular joint revision due to intractable pain and metal allergy.The surgeon reported the presence of a little bit of fibrous tissue and granuloma around the prosthesis indicative of an allergic reaction.The surgeon reported the device was in pristine condition, screw position was perfect and the fit was good.A spacer was placed after the removal of the prosthesis.No additional patient consequences were reported.
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.A revision surgery was performed, where the implants were removed and replaced with a spacer, therefore the complaint is confirmed.No products were returned, therefore no visual inspections or functional testing could be conducted.No x-rays, scans, or photos were provided.The devices were implanted (b)(6) 2014 and explanted (b)(6) 2019.It was reported that the patient had a pristine device, perfect screw position, and a good fit.The device had a little bit of fibrous tissue and granuloma around prosthesis indicative of an allergic reaction.The most likely underlying cause of the complaint is due to a patient condition.There was no allegation made against the implants themselves.This is the only complaint regarding a revision surgery to replace the implant due to allergic reaction and pain for this mandible (item# 24-6551, lot# 461850a) and fossa (item# 24-6561, lot# 417370c) component.The non-conformance database (tipqa) was reviewed no non-conformances were found.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: TMJ SYSTEM LEFT FOSSA COMPONENT, MEDIUM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8897695
• Report Number: 0001032347-2019-00390
• Device Sequence Number: 16493898
• Product Code: LZD
• UDI-Device Identifier: 00841036036546
• UDI-Public: 00841036036546
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6561
• Device Lot Number: 417370C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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: Hospitalization; Required Intervention