MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE BALICE PM-TMJ & MODEL; CUSTOM MADE TMJ

Model Number N/A

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).A patient information, height: 173 cm.Initial reporter also sent report to fda: the user facility is foreign; therefore a facility medwatch report will not be available.Report source - (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the implants did not fit as expected and the right cutting guide broke.The mandibular component on the left side is not properly fixed in the fossa as it is too much to the front side; on the right side, the fossa had to be placed oblique.There was a 60-90 minute surgical delay due to both the fossa and mandible components not fitting the anatomy as planned.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.As a picture of the fractured device was provided, the fracture portion of the complaint is considered confirmed.As the products were conforming to design specifications and no post-operative x-rays, scans, or physicians reports were provided, the fit portion of this complaint could not be confirmed.The dhrs of the components for tmjpm-2391 were reviewed and a non-conformance was found.This nc was in regards to a suture hole missing from this component and the component was reworked and reinspected accordingly.No additional anomalies were identified.This is a custom device with no similar devices and the lot quantity is one.Therefore there are no similar complaints and the risks associated with this device are unique to this device.The most likely underlying cause of the fracture portion of the complaint is that the sample experienced excessive force beyond what it is designed to encounter.No product was returned and no functional tests or inspections could be performed.For these reasons, the fit portion of the complaint could not 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.

Event Description

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

• Brand Name: CUSTOM MADE DEVICE BALICE PM-TMJ & MODEL
• Type of Device: CUSTOM MADE TMJ
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8474303
• MDR Text Key: 140670945
• Report Number: 0001032347-2019-00198
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-2391
• Device Lot Number: 891300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 114