MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN SCREW; PLATE, BONE

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems Implant Pain (4561); Swelling/ Edema (4577)

Event Date 06/09/2022

Event Type  Injury  

Event Description

It is reported that the patient underwent a right side tmj implant procedure, and consequently is experiencing pain and swelling.It was found that the previous surgeon had placed the fossa component too near to the ear canal and a revision is being planned for an unknown date in the future.It has been further reported that that the mandibular head is not seated properly in the cup and may have partially dislocated laterally.Additionally, the two most anterior screws holding the fossa in place extend significantly bicortically through the zygomatic arch.The area they extend into is right where the temporalis muscle sits.The patient will not undergo a revision procedure due to the patient's anatomy.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical products unknown tmj right fossa, unknown tmj right mandible, unknown screw qty 1.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2022-00201, 0001032347-2022-00262, 0001032347-2022-00270.

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.The case was reviewed by 3d systems during the design process of a possible replacement patient matched tmj device.3ds provided images of the patient's anatomy from the surgeon, which confirmed the report that the fossa is too near the ear canal.The mandibular head is displaced laterally and is not mating with the center of the fossa component.The images also confirm the report that two of the fossa screws are extending bicortically through the zygomatic arch.It has been reported that a joint revision was not possible due to patient anatomy.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 b4, b5, g3, g6, h2, h3, h6 and h10.

Event Description

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

Manufacturer Narrative

This report is being submitted to update additional information in section a2, b4, b5, g3, g6, h2, h3, and h10.

Event Description

It has been further reported that the surgeon is considering a revision procedure for this patient and is requesting patient matched implants.

• Brand Name: UNKNOWN SCREW
• Type of Device: PLATE, BONE
• 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: 15321259
• MDR Text Key: 298896726
• Report Number: 0001032347-2022-00268
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/08/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 10/12/2022; 11/22/2022
• Supplement Dates FDA Received: 10/19/2022; 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 47 YR
• Patient Sex: Female