MAUDE Adverse Event Report: ZIMMER DENTAL IMP, TSV, 3.7, 13, MTXF, MG,HA; DENTAL IMPLANT

Model Number	TSVTH13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Fax number and last/given name unknown / not provided.
Event or Problem Description
It was reported that the implant was removed due to the patient having worsening refractory pain and swelling since placement.Edema and inflammation also reported.Tooth #13.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: h6: component code was added: 4755.H6: tyoe of investigation codes were added: 4109, 4111, 4110 and 3331.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 4310 and 4315.One (1) imp, tsv, 3.7, 13, mtxf, mg,ha (tsvth13) was returned for investigation.Visual evaluation of the as returned product identified no apparent malfunction.Signs of use only.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot number (1239688) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Sterilization record (op#120) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review by lot number (1239688) was performed for similar events using keyword (medical: pain) and no other similar complaint was identified.The reported event could not be recreated due to the nature of the dental device and event (pain) and the complaint is not related to the functional performance of the device.A definitive root cause could not be identified.However, based on the investigation and risk review, the most likely causes for the reported event is implant material rejection; allergies, sensitivity.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional information received at the time of this report.

• Brand Name: IMP, TSV, 3.7, 13, MTXF, MG,HA
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11876140
• Report Number: 0002023141-2021-01387
• Device Sequence Number: 3559715
• Product Code: DZE
• UDI-Device Identifier: 00889024344310
• UDI-Public: (01)00889024344310(17)251108(10)1239688
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K133339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 11/08/2025
• Device Model Number: TSVTH13
• Device Catalogue Number: TSVTH13
• Device Lot Number: 1239688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/16/2021
• 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