MAUDE Adverse Event Report: BIOMET MICROFIXATION KM LEFT PM-TMJ & MODEL; CUSTOM TEMPOROMANDIBULAR JOINT REPLACEMENT

Model Number N/A

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Report source: foreign source: austria.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.

Event Description

It was reported a patient had an initial tmjpm.During this procedure a large intra-oral tumor was dissected, increasing the difficulty and or time to approximately 10 hours.The mandibular osteotomy had to be done a bit more aggressive which resulted with the use of only four mandibular screws for fixation.The head and neck was dissected during the initial operation and the surgical site was covered by a latissmus dorsi free flap.Subsequently, patient is being planned for a pmi product due to loosening of the mandibular component.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10 ¿ medical products: item # unk, lot # unk; unknown screw.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the tmjpm device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to a patient condition, as a large intraoral tumor resulted in the surgeon changing the planned bone resection.The designer of this device, 3d systems, was notified of this event and an investigation was conducted.The surgeon took an aggressive approach due to a large intraoral tumor, resulting in a larger mandibular resection than planned.This resulted in the surgeon only being able to place four of the seven planned screws.It is likely that the mandible component is loose because only four of the seven screws were utilized.This case was planned to be revised with a new custom implant to implant a larger mandible component that will wrap more of the patient's remaining anatomy.Review of the dhr shows that all parts were designed properly per the applicable work instructions and inspections.A definitive root cause 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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2023-00296.

Event Description

It is further reported that the patient is seeking alternative treatment instead of being revised.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h6 and h10.A supplemental medwatch was sent with a notification date of july 31, 2023, in g3 and submitted on august 11, 2023; however the correct notification date is jul 25, 2023.

Event Description

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

• Brand Name: KM LEFT PM-TMJ & MODEL
• Type of Device: CUSTOM TEMPOROMANDIBULAR 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: 16511179
• MDR Text Key: 310949007
• Report Number: 0001032347-2023-00076
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00888233047531
• UDI-Public: (01)00888233047531(17)261028(10)078910
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-3484
• Device Lot Number: 078910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Male