MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 12MM; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Urticaria (2278); Reaction (2414)
Date of Event	07/22/2020
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: 0001032347-2020-00490, 0001032347-2020-00491, 0001032347-2020-00492, 0001032347-2020-00494, 0001032347-2020-00495.Medical products: tmj system right fossa component, small, part# 24-6562, lot# 688990b; tmj system right standard titanium mandibular component 45mm / 7 hole, part# 24-6545ti, lot# 828150c; 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 12mm, part# 91-2712, 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 11mm, part# 99-6581, lot# ni.Occupation ¿ patient.
Event or Problem Description
It was reported the patient underwent a revision to remove temporomandibular joint implants on the right side due to allergic reaction.The patient did not receive replacement implants.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
It was reported the patient underwent a revision to remove temporomandibular joint implants on the right side due to allergic reaction eight (8) months following implantation.The patient reports there was an allergy test prior to implantation that confirmed a nickel allergy but there was no indication of a titanium allergy at that time.One (1) month following implantation, the patient experienced redness, itching and hives on the jaw, ear, throat and neck.A titanium allergy was confirmed approximately two (2) months following implantation.The patient was prescribed nine (9) medications to treat a reported facial infection.The patient is currently on iv medication for eight (8) weeks following an eye reaction that occurred following the removal of the implant.The patient is discussing implant replacement options with their surgeon.No additional patient consequences have been reported.
Event or Problem Description
No further event information available at the time of this report.
Additional 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 involved in this case.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.

• Brand Name: 2.4MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW 2.7MM X 12MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10637425
• Report Number: 0001032347-2020-00493
• Device Sequence Number: 1179094
• Product Code: HWC
• UDI-Device Identifier: 00841036053659
• UDI-Public: 00841036053659
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K001238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 91-2712
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 10/12/2020; 02/26/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/14/2020; 03/04/2021
• 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: Hospitalization; Required Intervention