MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,6.0MM,10MM,MTX; DENTAL IMPLANT

Catalog Number	TSVM6B10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Zonular Dehiscence (2698)
Date of Event	06/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).G4: additional 510(k) number is k101880.
Event or Problem Description
It was reported, that the implant at tooth site #19 (universal) was removed, due to infection.When site was explored, a dehiscence was found and the implant was removed.Symptoms as a result of the event: pain, swelling & inflammation.
Event or Problem Description
No additional event information received at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4110, 4111 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4310.H10: narrative/data was updated.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.Sterilization record 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 for similar events and 2 other relevant complaint(s) were identified.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.As documented in the summary investigation, contributing factors for the reported event likely exist outside of zimvie control, including those related to patient biological factors/condition and surgical technique.Based on the summary investigation, no malfunction occurred upon investigation.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 the infection of an implant have not identified any signals indicating potential non-conformances impacting the manufacturing and sterilization processes.Therefore, escalation to capa is not required.

• Brand Name: IMP,TSV,MCOL MG,6.0MM,10MM,MTX
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 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: 20084507
• Report Number: 0002023141-2024-02813
• Device Sequence Number: 7562158
• Product Code: DZE
• UDI-Device Identifier: 00889024019676
• UDI-Public: (01)00889024019676(17)290116(10)1275844
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111889
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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 Catalogue Number: TSVM6B10
• Device Lot Number: 1275844
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2024
• Is the Reporter a Health Professional?: Yes
• 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: 08/28/2024
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2024
• 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: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic