MAUDE Adverse Event Report: BIOMET 3I 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(L); DENTAL IMPLANT

Catalog Number	BOES505
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A2: patient age is not provided / unknown.A4: patient weight is not provided / unknown.E1: initial reporter¿s title is not provided / unknown.
Event or Problem Description
It is reported that the implant was removed due to bone loss.Tooth site 47.
Additional Manufacturer Narrative
This report is being submitted to report additional and corrected information to 0001038806-2024-00364.The expiration date has been corrected to 8/1/2024.The following sections are being reported: d4: expiration date.D9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.A summary investigation has been completed for bone loss events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for bone loss have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss and escaping the available detections has been assessed and found remote and almost nonexistent.Dhr review was completed for the subject lot number.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.As documented in the summary investigation, contributing factors for the reported event likely exist outside of zimvie control, including those related to medical conditions / patient habits and surgical technique.Based on the summary investigation, no malfunction occurred upon investigation and no association between the dental implant and bone loss was found that can explain these events.Therefore, the reported event remains non-verifiable as it is a medical condition.Monthly trending to date has not identified any statistical triggers suggesting potential design or manufacturing related issues.Previously completed investigations for bone loss problems reported in association with implant failure have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Therefore, escalation to capa is not required.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: 3I T3 SHORT EXTERNAL HEX PARALLEL WALLED IMPLANT, 5MM(D) X 5MM(L)
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18833167
• Report Number: 0001038806-2024-00364
• Device Sequence Number: 17953381
• Product Code: DZE
• UDI-Device Identifier: 00844868033639
• UDI-Public: (01)00844868033639(17)240801(10)2019070897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150571
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 07/31/2024
• Device Catalogue Number: BOES505
• Device Lot Number: 2019070897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic