MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 3.7MM MTX FULL,11.5MM; DENTAL IMPLANT

Model Number	TMTB11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports a chronic infection in the implant area after about five (5) years of use.The affected dental positions are: #11 #21 #16 #26 and #27.The doctor reports: pain and inflammation.The doctor reports that the procedure was not completed with the placement of other implants.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
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.Dhr review was completed for the associated subject lot numbers 63390567, 63444620, 63399196, & 63570377.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 dhrs.Lots were inspected and passed all acceptance criteria by qa.Sterilization record review was performed for the associated lot numbers 63390567 (st# 3021), 63444620 (st# 3068),63399196 (st# 3029) & 63570377 (st# 3154) and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot numbers 63390567 & 63399196 for similar events and 1 other relevant complaint was identified for both.Complaint history review was performed for the associated lot numbers 63444620 & 63570377 for similar events and no other complaint was identified.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMP TM 3.7MM 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16152399
• Report Number: 0002023141-2023-00155
• Device Sequence Number: 7396556
• Product Code: DZE
• UDI-Device Identifier: 00889024019003
• UDI-Public: (01)00889024019003(10)63399196(17)210630
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: TMTB11
• Device Catalogue Number: TMTB11
• Device Lot Number: 63399196
• 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: 04/13/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2016
• 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: 63 YR
• Patient Sex: Female