MAUDE Adverse Event Report: ZIMMER DENTAL IMP TM 4.7MM MTX, 10MM; DENTAL IMPLANT

Model Number	TMMWB10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Additional pma/510(k) number: k113753, k112160.A summary investigation has been completed for bone loss 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 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
It was reported that implant was removed due to bone loss.Patient complaint of bad taste on several occasions; however no signs of infection was noted.Deep pocketing and bone loss was reported and implant was removed.
Additional Manufacturer Narrative
This report has been relayed to correct and error in the previously reported submission (mfr# 0002023141 - 2020 - 01912).The following section has been corrected: d4: unique identifier (udi) number: not provided/ unk.
Event or Problem Description
No further event information available at the time of this report.Tooth location 14.

• Brand Name: IMP TM 4.7MM MTX, 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10805844
• Report Number: 0002023141-2020-01912
• Device Sequence Number: 2874994
• Product Code: DZE
• UDI-Device Identifier: 00889024018907
• UDI-Public: (01)00889024018907(17)180831(10)62455138(241)TMMWB10
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: TMMWB10
• Device Catalogue Number: TMMWB10
• Device Lot Number: 62455138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: 68 YR