MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.1MM MTX FULL, 11.5MM; DENTAL IMPLANT

Model Number	TMT4B11
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Pma/510k: k113753, k112160.
Event or Problem Description
It was reported that implant was loose and when removed, the implant was split off where trabecular metal starts.The other half is still in the patient fully integrated at site #3.As a result of the event no injury to the patient was reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
An imp tm 4.1mm mtx full, 11.5mm (tmt4b11) was returned for investigation.Visual inspection of the as returned product identified slightly dried blood and a fracture at the threads above the tm junction.No pre-existing conditions were noted on the per.Pictures or x-ray images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1217563).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 was 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 (1217563) for similar event and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: IMP TM 4.1MM MTX FULL, 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11434609
• Report Number: 0002023141-2021-00557
• Device Sequence Number: 3105659
• Product Code: DZE
• UDI-Device Identifier: 00889024018945
• UDI-Public: (01)00889024018945(17)230620(10)1217563
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: Lay User/Patient
• Device Expiration Date: 06/20/2023
• Device Model Number: TMT4B11
• Device Catalogue Number: TMT4B11
• Device Lot Number: 1217563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR