MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.7MM MTX FULL, 11.5MM; DENTAL IMPLANT

Catalog Number	TMTWB11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant was removed due to fracture.Symptoms as a result of the event: edema.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).A4: patient weight is not provided / unknown.G4: additional 510(k) numbers are k113753 and k112160.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Zimvie did not receive one (1) tmtwb11, (imp tm 4.7mm mtx full, 11.5mm), 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).Dhr review was completed for the subject lot number 1219141.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 1219141, for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : fracture : implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was and clinician selects implant that is unable to resist long-term occlusal loading.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.

• Brand Name: IMP TM 4.7MM MTX FULL, 11.5MM
• 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: 20034330
• Report Number: 0002023141-2024-02743
• Device Sequence Number: 6423843
• Product Code: DZE
• UDI-Device Identifier: 00889024019041
• UDI-Public: (01)00889024019041(17)231010(10)1219141
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/09/2023
• Device Catalogue Number: TMTWB11
• Device Lot Number: 1219141
• 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: 08/22/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic