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

Model Number	TMT4B10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Osteolysis (2377); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Pma/510(k) number: k113753 and k112160.
Event or Problem Description
It was reported that two implants fractured after five (5) years of use.The implants were removed the implants using trephine.The doctor reported that the procedure was not compatible with the placement of other implants.Osteolysis reported as a consequence of the event.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.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.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.Two (2) imp tm 4.1mm mtx full, 10m (tmt4b10) were returned for investigation.Visual evaluation identified that the implants were fractured at the bottom section and that the collar section was not returned.There were signs of use and bone debris on the external threads.Zimvie is not responsible for any damage caused by the clinician's removal of the device.Functional testing to recreate the reported event could not be performed due to the nature of the devices & event.Pre-existing condition noted on the per was moderate bone density (type ii).The reported devices were at tooth location 45,46, and 47 (universal) for approximately 5 years, 1 month.Dhr review was completed for the subject lot number, 63430650.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Review completed utilizing keywords: fracture: implant therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).

• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16156111
• Report Number: 0002023141-2023-00170
• Device Sequence Number: 7396415
• Product Code: DZE
• UDI-Device Identifier: 00889024018938
• UDI-Public: (01)00889024018938(10)63430650(17)210731
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

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: 07/31/2021
• Device Model Number: TMT4B10
• Device Catalogue Number: TMT4B10
• Device Lot Number: 63430650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 04/17/2023; 06/09/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 05/02/2023; 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2016
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 91 KG