MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

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

Patient Problems Ossification (1428); Rheumatoid Arthritis (1724); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00256, 0001032347-2021-00258, 0001032347-2021-00259.Medical products: tmj system left fossa component, small, part# 24-6563, lot# 444030a.Tmj system left standard mandibular component 45mm / 7 hole, part# 24-6546, lot# 466480a.Tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 409250a.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# 015250.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# 705230.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# 806180.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# 129510.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# 273070.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# 806190.2.7mm system emergency cross drive screw, 1/pkg 3.2x10mm, part# 99-9950, lot# wl3290.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot# 015170.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot# 300130.2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, lot# 429210.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# 015150.2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# 541420.(b)(6).

Event Description

It was reported the patient will undergo a revision of bilateral temporomandibular joint implants seven (7) years following implantation due to reankylosis with heterotopic bone formation in the left joint.The patient will receive a custom bilateral temporomandibular joint implant at a future unspecified date.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D6b ¿ explantation date is planned for (b)(6) 2021.

Event Description

It was reported the patient will undergo a revision of bilateral temporomandibular joint implants seven (7) years following implantation due to reankylosis with heterotopic bone formation in the left joint, pain and total restriction of mouth opening.It is planned that the patient will receive a custom bilateral temporomandibular joint implant in three (3) months.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.Review of the device history records identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported items and no additional complaints for the reported part and lot combinations.Medical records were not 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 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: TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 11808233
• MDR Text Key: 254499082
• Report Number: 0001032347-2021-00257
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036560
• UDI-Public: (01)00841036036560
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6562
• Device Lot Number: 470250B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG