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

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (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: 0001032347-2020-00309, 0001032347-2020-00310, 0001032347-2020-00311, 0001032347-2020-00312, 0001032347-2020-00313, 0001032347-2020-00315, 0001032347-2020-00316, 0001032347-2020-00317.Medical products: tmj system right fossa component, small, part# 24-6562, lot# 809800c; tmj system left standard titanium mandibular component 45mm / 7 hole, part# 24-6546ti, lot# 721720b; tmj system left fossa component, small, part# 24-6563, lot# 839240c; tmj system right standard titanium mandibular component 50mm / 9 hole, part# 24-6550ti, lot# 780140b; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni; 2.4mm system high torque (ht) cross-drive screw 2.7 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; tmj system cross drive fossa screw 2.0mm x 11mm, part# 99-6581, lot# ni.Occupation ¿ patient representative.
Event or Problem Description
It was reported that the patient is experiencing pain with their bilateral temporomandibular joint implants two (2) years following implantation.The patient reports that the implants are sitting incorrectly in the condyles of the patient¿s face and are pressing back on the ear bone.The patient reports the implants will be removed at a future unspecified date.No additional patient consequences have been reported.
Event or Problem Description
It was reported that the patient is experiencing pain following implantation of bilateral temporomandibular joint implants two (2) years ago.The patient reports that the implants are sitting incorrectly in the condyles of the patient¿s face, are sitting too far back, and are pressing on the ear canal.The patient is receiving botox for pain management.There is no revision planned at this time.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because this information was provided by the patient's power of attorney and mentions numerous post-operative meetings with surgeons.No product was returned because they remain implanted; therefore, no functional testing or visual evaluations could be conducted.No photos, scans, or x-rays were received.The dhrs for the screws involved in this case were not reviewed due to the lot numbers being unknown.There are no indications of manufacturing defects.The most likely underlying cause of the complaint could not be determined from the information provided.It is possible that the devices were not implanted in the optimal position or the patient's anatomy was unique and should have required a patient matched tmj device.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 2.7 X 10MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10267526
• Report Number: 0001032347-2020-00314
• Device Sequence Number: 2329607
• Product Code: HWC
• UDI-Device Identifier: 00841036053642
• UDI-Public: 00841036053642
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 12/16/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 11/03/2020; 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention