MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® IMPLANT 3.25 X 8.5MM; DENTAL IMPLANT

Model Number	IOSM385
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to bone loss.
Additional Manufacturer Narrative
Zimvie complaint #: (b)(4).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.
Additional Manufacturer Narrative
Multiple mdr reports are filed for this event.See 0001038806-2022-00778, 0001038806-2022-00778-1, 0001038806-2022-00781, and 0001038806-2022-00781-01.This report is being submitted to report additional information.The following sections are being reported: d9: device availability.H2: if follow-up, what type.H3: device evaluated by manufacturer.H6: type of investigation.H10: additional narratives/data.Dhr review was completed for the subject lot number.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 dhrs.Lot was inspected and passed all acceptance criteria by qa.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 zimmer biomet 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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: OSSEOTITE® CERTAIN® IMPLANT 3.25 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: 14515335
• Report Number: 0001038806-2022-00780
• Device Sequence Number: 5487976
• Product Code: DZE
• UDI-Device Identifier: 00844868007074
• UDI-Public: (01)00844868007074(17)211129(10)2016111425
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

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: 11/29/2021
• Device Model Number: IOSM385
• Device Catalogue Number: IOSM385
• Device Lot Number: 2016111425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2016
• 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: 68 YR
• Patient Sex: Female