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

Model Number N/A

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

Patient Problems Pain (1994); Deformity/ Disfigurement (2360); Insufficient Information (4580)

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.Concomitant medical products: unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Report source ¿ (b)(6).

Event Description

It was reported the patient will undergo a revision of bilateral temporomandibular joint implants at a future date.It is planned that the patient will receive a replacement of custom bilateral titanium temporomandibular joint implants.Attempts have been made and no further information has been provided.

Event Description

It was reported the patient will undergo a revision of bilateral temporomandibular joint implants two (2) years following implantation due to pain and malocclusion.The patient will receive a custom bilateral tmj implant at an unspecified date.The bilateral fossa components will be removed at that time, and the fossa components were secured with sutures and not screws.The bilateral mandible components have been removed previously in an unknown revision.It was reported that no further information is available.

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.Part and lot identification are necessary for review of device history records, neither were provided.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.This report is being submitted to update additional information in section b2, b5, b7, d6a, h2, h3, h6 and h10.

Event Description

It was reported the patient will undergo a revision of bilateral temporomandibular joint implants two (2) years following implantation due to pain and malocclusion.The patient will receive a custom bilateral tmj implant at a future unspecified date.The fossa components will be removed at this time, as the bilateral mandible components have been removed previously.It was reported that no further information is available.

• Brand Name: UNKNOWN TEMPOROMANDIBULAR JOINT PROSTHESIS
• Type of Device: UNKNOWN TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11465107
• MDR Text Key: 239215092
• Report Number: 0001032347-2021-00108
• 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,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention