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

Model Number	TMT4B11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Additional pma/510(k) number ¿ k113753|k112160.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was having constant pain and wanted the implant removed.Implant #9 was removed and the area was grafted.The patient is not returning for future implant placement.Symptoms as a result of the event: inflammation.
Event or Problem Description
No additional event information at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67 and 4310.H10: narrative/data was updated.One imp tm 4.1mm mtx full, 11.5mm (tmt4b11) was returned for investigation.Visual evaluation of the as returned product identified signs of usage and what appears to be bone tissue/debris attached to the implant external threads and dried blood inside the drive feature.No significant damage was identified.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number 1240266.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.Sterilization record (op#(b)(4)) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review by lot number (1240266) was performed for similar events using keyword (medical pain) and no other similar complaint was identified.The reported event could not be recreated due to the nature of the dental device and event (pain) and the complaint is not related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk review, the most likely cause for the reported event is patient factors and improper surgical practices.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.

• 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
• 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: 12572706
• Report Number: 0002023141-2021-02758
• Device Sequence Number: 924262
• Product Code: DZE
• UDI-Device Identifier: 00889024018945
• UDI-Public: (01)00889024018945(17)251005(10)1240266
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2022

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: 10/05/2025
• Device Model Number: TMT4B11
• Device Catalogue Number: TMT4B11
• Device Lot Number: 1240266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• 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: 09/10/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2020
• 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 Sex: Female