MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL,10M; DENTAL IMPLANT

Catalog Number	TMT4B10
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported allergic reaction.Tooth site # 45.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: phone number (b)(6).G4: pma/510(k) number k113753, k112160.
Additional Manufacturer Narrative
Zimvie did not receive one (1) tmt4b10, (imp tm 4.1mm mtx full,10m) 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).Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1242775.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 1242775 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿allergic reaction¿.The customer did submit one (1) image for the reported event.(see attachments tab at ce level).Ifu review: documents reviewed: instructions for use ¿ tapered screw-vent® and trabecular metal¿ implants - 4869 rev.10-03/24.Information identified: "adverse effects".Based on the investigation and risk management file review as per rmf rm-00541-haz rev.4, the most likely root cause determined from the investigation is external factors (i.E.Patient conditions.) 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 product was 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." h3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative.H3 other text: device was not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP TM 4.1MM MTX FULL,10M
• 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: 18873514
• Report Number: 0002023141-2024-00662
• Device Sequence Number: 3022872
• Product Code: DZE
• UDI-Device Identifier: 00889024018938
• UDI-Public: (01)00889024018938(17)260322(10)1242775
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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: Health Professional
• Device Expiration Date: 03/21/2026
• Device Catalogue Number: TMT4B10
• Device Lot Number: 1242775
• Was Device Available for Evaluation?: No
• 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: 03/11/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic