MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE CERTAIN IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Catalog Number	IOSM311
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	06/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report additional information.The customer confirmed the lot number.Multiple reports are being submitted for this event.The following sections are being reported: d4: lot number.H2: if follow-up, what type.H10: additional narratives/data.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Dhr review was completed for the subject lot number 2016110519.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 2016110519 for similar events and two other complaints were identified.Review completed utilizing keywords: bone loss.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.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Multiple reports are being submitted for this event.A1: patient identifier is (b)(4)).E1: initial reporter¿s title is not provided / unknown.
Event or Problem Description
It was reported that the implant was removed due to bone loss.

• Brand Name: OSSEOTITE CERTAIN IMPLANT 3.25 X 11.5MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 20278354
• Report Number: 0001038806-2024-02143
• Device Sequence Number: 7980090
• Product Code: DZE
• UDI-Device Identifier: 00844868007036
• UDI-Public: (01)00844868007036(17)211213(10)2016110519
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063341
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2025

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: 12/12/2021
• Device Catalogue Number: IOSM311
• Device Lot Number: 2016110519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 09/30/2024; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic