MAUDE Adverse Event Report: ZIMVIE US CORP LLC IMP,TSV, 4.1,11, MTX,MC,M; DENTAL IMPLANT

Catalog Number	TSVM4H11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Osteolysis (2377)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
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 corrected data and additional information.Correction: the reported implant placement date of (b)(6) 2024 is prior to the device manufacture date of (b)(6) 2024.Implant placement date is being updated to unknown.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.D6a: implant placement date was removed.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H10: narrative/data was updated.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided 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 non-existent.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
It was reported that the implant at tooth site #10 did not heal and bone did not fill in around the implant.There was active infection prior to placement that may have been the causing factor.The implant was removed due to bone loss.Symptoms as a result of the event: inflammation.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: the device catalog number was updated from tsvm4h10 to tsvm4h11.
Event or Problem Description
Additional information was received updating the catalog number.

• Brand Name: IMP,TSV, 4.1,11, MTX,MC,M
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23523521
• Report Number: 0001038806-2025-03075
• Device Sequence Number: 21278493
• Product Code: DZE
• UDI-Device Identifier: 00889024344006
• UDI-Public: (01)00889024344006(17)291213(10)1289559
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K133339
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/13/2026

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: Other
• Device Catalogue Number: TSVM4H11
• Device Lot Number: 1289559
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 11/11/2025
• Supplement Report FDA Received Date: 01/06/2026; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic