MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,6.0,13,MTX,MG; DENTAL IMPLANT

Model Number	TSVT6B13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Pma/510k: additional 510(k) number is k101880.A summary investigation has been completed for bone loss and infection 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 bone loss and infection have not identified any signals indicating potential non-conformances affecting the manufacturing and sterilization processes.Furthermore, the probability of manufacturing or design defects that might lead to bone loss 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.
Event or Problem Description
The clinician reported infection at the implant site and the implant was removed.Patient was sent home to heal for 4-6 months.Tooth site # 31 (universal).Inflammation, pain and bone loss was also noted.
Additional Manufacturer Narrative
This medwatch is being submitted to relay corrected information.Upon follow up with the customer, it was reported that the implant date that was previously reported, could not be confirmed.The customer does not have access to the files anymore.This medwatch report is submitted to report that the implant date is unknown.The following sections are being reported: d6 d6a.If implanted, give date was corrected.H2: type of follow up was updated.H10: narrative/data was updated.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: IMP,TSV,6.0,13,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12094292
• Report Number: 0002023141-2021-01669
• Device Sequence Number: 3960126
• Product Code: DZE
• UDI-Device Identifier: 00889024019898
• UDI-Public: (01)00889024019898(17)210831(10)63415510
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 08/31/2021
• Device Model Number: TSVT6B13
• Device Catalogue Number: TSVT6B13
• Device Lot Number: 63415510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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: 60 YR