MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN TMJ; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

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.The device was originally implanted in 2009.Concomitant medical products ¿ unknown screws, part# unknown, lot# unknown.The user facility is foreign; therefore a facility medwatch report will not be available.Report source ¿ (b)(6).

Event Description

It was reported the patient will undergo a revision of temporomandibular prostheses due to malocclusion and loosening of anterior screws.The implants will be replaced by a custom device.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 as a revision surgery was reported.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, or pictures were provided.Four follow up attempts were made for additional information including the identity of the products being removed; however, no additional information was obtained.The dhrs could not be reviewed for these parts due to the part and lot numbers being unknown.There are no indications of manufacturing defects.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding implants loosening, there is a complaint rate of 0.149%, 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 implants loosening, there is a complaint rate of 0.191%, 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 0.446%, 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 malocclusion, there is a complaint rate of 0.477%, which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the complaint cannot be determined.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.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: UNKNOWN TMJ
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9375575
• MDR Text Key: 167996164
• Report Number: 0001032347-2019-00512
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN TMJ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 04/29/2020
• 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