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

Model Number	TMT4B10
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight not provided.Additional 510(k) numbers are k113753 and k112160.
Event or Problem Description
It was reported that the patient had continuous pain after placement.An allergic reaction was suspected.By the time of implant removal an infection was present.Non integration and inflammation were also reported.
Additional Manufacturer Narrative
One (1) imp tm 4.1mm mtx full,10m (tmt4b10) was returned for investigation.Visual evaluation of the as returned product identified both implants with no damage, or signs of malfunction that would contribute to the event.Measurements match drawing.Cal3845 (due: sep 12, 2022) functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was low bone density (type iii), diabetes.The reported device was used for approximately 28 days.The customer did not provide any pictures or x-rays.Review of appropriate documentation: documents reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Information identified: contraindications, warnings, precautions and adverse effects.Per the applicable ifu, local and generalized allergic reactions are listed as adverse effects.Also, it is stated that some adverse effects may occur as a result of iatrogenic factors and host responses.Dhr review: dhr review was completed for the subject lot numbers (63482687).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 numbers were inspected and passed all acceptance criteria by qa.Sterilization record review: all sterilization activities were conducted with no nonconformities per sterilization records.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review: complaint history review was performed for the reported lot numbers (63482687) for similar events (complaint category keywords: medical: allergic reaction) and no other complaint was identified.Post market trending review: feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event (medical allergic reaction) or product (tmt4b10).No actionable items have been triggered that will affect complaint handling on our end for this month.Therefore, based on the available information, device malfunction did not occur.The reported event could not be verified as the exact details of event were nonverifiable.
Event or Problem Description
There is no update to the original complaint description provided.

• 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: 12797461
• Report Number: 0002023141-2021-03231
• Device Sequence Number: 20245052
• Product Code: DZE
• UDI-Device Identifier: 00889024018938
• UDI-Public: (01)00889024018938(17)210930(10)63482687
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: TMT4B10
• Device Catalogue Number: TMT4B10
• Device Lot Number: 63482687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2016
• 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: 62 YR
• Patient Sex: Female