MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE; TOTAL TEMPROMANDIBULAR JOINT REPLACEMENT

Model Number N/A

Device Problems Fitting Problem (2183); Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported that a revision is planned as the product did not fit as expected.The patient's occlusion is off on both sides.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint cmp-(b)(4).Foreign - germany.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The designer of this device, 3d systems, was notified of this complaint and an investigation was conducted into the reported event.It was noted that there were marked differences between the scan that was used to create deliverables and the scan that was sent for post-op review.It was found that the post-op scan was approximately 0.5mm smaller in every dimension and appears far more pixelated.It was also determined that there were significant differences between the planned positions of the deliverables and anatomy from the actual post-op.The mandible and maxilla implant positions were placed notably more posterior than initially planned.This variation likely led to the reported poor patient occlusion.The post-op scans show that there was less bone removed from the condyle than was planned.The mandible implant was then likely unable to be placed in the planned position as it could have resulted in interference between the condyle and fossa components.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: CUSTOM MADE DEVICE
• Type of Device: TOTAL TEMPROMANDIBULAR JOINT REPLACEMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16096699
• MDR Text Key: 306638778
• Report Number: 0001032347-2023-00001
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00888233060196
• UDI-Public: (01)00888233060196(17)270923(10)144220
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• 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: TMJPM-3780
• Device Lot Number: 144220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization