MAUDE Adverse Event Report: BIOMET 3I 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 8.5MM; DENTAL IMPLANT

Model Number	BNPT4385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	11/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of pain, and infection was discovered with abscess showing on radiograph around the implant at tooth location #28.The implant was removed.Symptoms as a result of the event: inflammation and pain.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the reported device was not returned for evaluation.The following sections are being reported: b4: date of this report was updated.D9: product availability and return date was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: type of investigation code was added: 3331, 4110 and 4114.H10: narrative/data was updated.Dhr review was completed for the subject lot number (2019120872).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Sterilization record (op0210) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2019120872) for similar event and no other complaint was identified.Post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.As documented in the summary investigation, contributing factors for this reported event likely exist outside of zimvie control, including those related to patient biological factors/condition and surgical technique.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: 3I T3 WITH DCD TAPERED IMPLANT 4/3 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16304997
• Report Number: 0001038806-2023-00227
• Device Sequence Number: 6185230
• Product Code: DZE
• UDI-Device Identifier: 00844868028352
• UDI-Public: (01)00844868028352(17)250116(10)2019120872
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2023

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: Lay User/Patient
• Device Expiration Date: 01/16/2025
• Device Model Number: BNPT4385
• Device Catalogue Number: BNPT4385
• Device Lot Number: 2019120872
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female