MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TM 3.7MM MTX FULL,13M; DENTAL IMPLANT

Catalog Number	TMTB13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported that after implants were placed the patient resumed high-impact physical activities too soon after surgery, leading to accidental trauma to the implant area.The repeated force caused early implant loosening and failure.Pain was reported as a result of the event.Patient will return to complete the procedure.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d9: device availability g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative zimvie received one (1) tmtb13, (imp,tm 3.7mm mtx full,13m) for evaluation.Visual evaluation was performed, the returned implant has signs of wear/use.However, no damage or signs of malfunction that would have contributed to the event.Dhr review was completed for the subject lot number 1268618.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 1268618 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : other and dental : functional : lack of primary stability.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was external factors (i.E.Patient conditions).Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP,TM 3.7MM MTX FULL,13M
• 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: 21958905
• Report Number: 0002023141-2025-01180
• Device Sequence Number: 7265166
• Product Code: DZE
• UDI-Device Identifier: 00889024019010
• UDI-Public: (01)00889024019010(17)280709(10)1268618
• Combination Product (Y/N): N
• Initial Reporter Country: GG
• PMA/510(K) Number: K132258
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: TMTB13
• Device Lot Number: 1268618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic