MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 6.0MM MTX, 11.5MM; DENTAL IMPLANT

Model Number	TMM6B11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Osteolysis (2377)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight is not provided / unknown.Additional 510(k) numbers are k113753 and k112160.Summary investigation.
Event or Problem Description
Peri-implantitis is reported.Patient was having issues with implant at tooth site #19 (universal), could feel threads of implant in bone.Implant was removed and area grafted with allograft.Symptom as a result of the event is inflammation.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: h2: type of follow up was updated.H10: narrative/data was updated.A summary investigation has been completed for peri-implantitis events recognizing that a definitive root cause cannot be identified due to a wide range of external factors (non-design or manufacturing related), including medical conditions (e.G., diabetes, poor bone quality, etc.) / patient habits (e.G., smoking) and surgical technique.Previously completed investigations for these events have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of a manufacturing or design defect that might lead to peri-implantitis occurring and escaping the available detections has been assessed and found remote and almost nonexistent.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.

• Brand Name: IMP TM 6.0MM MTX, 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12322193
• Report Number: 0002023141-2021-02129
• Device Sequence Number: 14443682
• Product Code: DZE
• UDI-Device Identifier: 00889024018846
• UDI-Public: (01)00889024018846(10)63198718(17)201031
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/14/2021

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: 10/31/2020
• Device Model Number: TMM6B11
• Device Catalogue Number: TMM6B11
• Device Lot Number: 63198718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/14/2021
• Supplement Date Received by Manufacturer: 08/14/2021
• Initial Report FDA Received Date: 08/14/2021
• Supplement Report FDA Received Date: 08/14/2021
• 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: 74 YR