MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 4.1, 1, MTX,MC,; DENTAL IMPLANT

Catalog Number	TSVM4H10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that the implant fell out of the mount.When removing the implant from the case, it fell out of the mount.The doctor commented that it was likely loose from the beginning.The doctor said he had seen similar cases twice before.The procedure was completed using another implant or another device.
Additional Manufacturer Narrative
Zimvie did not receive one (1) tsvm4h10, (imp, tsv, 4.1, 1, mtx,mc,) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1248307.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 1248307 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : disengaged the customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00541-haz, the most likely root cause determined from the investigation was clinician mishandles product.Therefore, based on the available information, a device malfunction could not be verified.Without device receipt, the reported event is 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.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) tsvm4h10, (imp, tsv, 4.1, 1, mtx,mc,) for evaluation.Visual evaluation / functional test was performed, no damage to the implant was identified.Malfunction was not identified as mount engaged/retained to implant during functional testing.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1248307.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 1248307 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: disengaged.The customer did not submit images for the reported event.Based on the investigation and risk management file review as per rm-00541-haz, the most likely root cause determined from the investigation was clinician mishandles product.Therefore, based on the available information, a device malfunction did not occur.The implant shows signs of usage however no malfunction identified.The reported event/coob is 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.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: IMP, TSV, 4.1, 1, MTX,MC,
• 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: 22506436
• Report Number: 0002023141-2025-01950
• Device Sequence Number: 15778723
• Product Code: DZE
• UDI-Device Identifier: 00889024343993
• UDI-Public: (01)00889024343993(17)261129(10)1248307
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133339
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: TSVM4H10
• Device Lot Number: 1248307
• 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; Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/17/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic