MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 10MM; SCREW, FIXATION, BONE

Model Number N/A

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Difficulty Chewing (2670)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as it remains implanted; 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: 0001032347-2020-00562, 0001032347-2020-00563, 0001032347-2020-00564, 0001032347-2020-00565, 0001032347- 0001032347-2020-00567, 0001032347-2020-00568.Concomitant medical products: tmj system right narrow mandibular component 50 mm / 7 hole, part# 01-6550, lot# 410290; tmj system left narrow mandibular component 50mm / 7 hole, part# 01-6551, lot# 694760; tmj system right fossa component, small, part# 24-6562, lot# 797600; tmj system left fossa component, small, part# 24-6563, lot# 753770; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni.Initial reporter occupation ¿ patient.

Event Description

It was reported the patient is experiencing pain and difficulty chewing eleven (11) years following implantation of bilateral temporomandibular joint implants.The patient indicates that the pain is better than before the surgery but is still being experienced.The patient reports that their jaw has shifted so that their teeth do not touch, and as a result the patient cannot chew or tear meat.The patient has broken several teeth due to bruxism and their dentist believes the breakages are due to trauma from the initial surgery.The patient receives botox shots for burning or firing nerves that cause pain.No additional patient consequences have been reported.

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.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.The reported products were reviewed for compatibility with no issues noted.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.

Event Description

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

Event Description

It has been further reported that the tmj patient reports that they are experiencing pain, pain in the ear, muscle tightness and that their jaw has shifted to where their teeth do not touch.Patient's jaw is locking and this is due to a calcium bone growth in her right joint of the device per a ct scan.Patient was told in order to resolve the issue a complete bi-lateral joint revision would be needed.In order to put off surgery, patient has gone to physical therapy to increase mobility and stretch inside of mouth.Patient is at 33 mm.Patient was referred back to her implant surgeon.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.There are no changes to the previous investigation outcomes.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.

• Brand Name: 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 10MM
• Type of Device: SCREW, FIXATION, 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10791428
• MDR Text Key: 214760368
• Report Number: 0001032347-2020-00566
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 00841036053642
• UDI-Public: 00841036053642
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 91-2710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female