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

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Erythema (1840); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (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: 0001032347-2019-00555.Medical products: tmj system left narrow mandibular component, part# 01-6546, lot# 873470d.Tmj system left fossa component, small, part# 24-6563, lot# 882250a.
Event or Problem Description
It was reported the patient underwent a revision of temporomandibular implants on the left side due to an unknown reason.No additional patient consequences were reported.
Event or Problem Description
It was reported the patient underwent a removal of temporomandibular joint implants and debridement on the left side two months post-operatively due to infection and dislocation.The patient complained of pain and experienced malocclusion, unresolved edema, and erythema at the left preauricular surgical site.After the patient underwent eight weeks of antibiotic treatment, the patient was implanted with new temporomandibular joint prostheses on the left side.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The date of event and explantation date initially reported were inaccurate and represented the date the new devices were implanted.The date of event and explantation date have been revised to report the date the original implants were removed.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, or pictures were provided.The operation notes were provided by the hospital for both the removal and the replacement surgeries.The dhr for the mandible component was reviewed; no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding malocclusion, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding infection, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding dislocation, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the infection could not be determined.It is possible that the reported bilateral degenerative arthritis led to the issues of malocclusion and dislocation.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
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9511431
• Report Number: 0001032347-2019-00554
• Device Sequence Number: 19387271
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2020

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 Expiration Date: 02/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 873470D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 01/15/2020; 05/28/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/06/2020; 05/28/2020
• 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