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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Erythema (1840); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 09/16/2019

Event Type  Injury  

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: 0001032347-2019-00554.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 Description

It was reported a patient underwent a revision for temporomandibular implants on the left side due to an unknown reason.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

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 fossa component was reviewed; no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, (b)(4).For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding malocclusion, there is a complaint rate of 0.50%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding infection, there is a (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 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.

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.The following fields were updated: a1 patient identifier b3 date of event b4 date of this report b5 describe event or problem d7 explantation date g4 date received by manufacturer g7 type of report h2 follow up type h6 patient code h6 device code h10 additional narratives/data.

• Brand Name: TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9511444
• MDR Text Key: 176986187
• Report Number: 0001032347-2019-00555
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: 00841036036584
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 882250A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/15/2020; 05/28/2020
• Supplement Dates FDA Received: 02/06/2020; 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention