MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,6.0,8,MTX,MG; DENTAL IMPLANT

Catalog Number	TSVT6B8
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932)
Date of Event	05/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that the implant placement went uneventful- isq-72, pt felt sore post-op and implant was mobile at 2 weeks, therefore it was removed due to allergic reaction and infection.Symptoms as a result of the event: inflammation.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).G4: pma/510(k) number k101880.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) tsvt6b8, (imp,tsv,6.0,8,mtx,mg) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, markings from removal and debris on its external threads.No damage identified or signs of malfunction that would have contributed to the reported events.Outer measurements match drawing.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1241829.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1241829 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿allergic reaction¿ & "infection" the customer did not submit images for the reported events.Based on the investigation and risk management file review as per rmf rm-00541-haz rev.4, the most likely root causes determined from the investigation are external factors (i.E.Patient conditions).Refer to attached summary investigation for ¿infection.¿ therefore, based on the available information, a device malfunction did not occur.The reported events were non-verifiable with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Similar complaints for implant infection have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.While non-conformances were identified for some lots during manufacturing record reviews, the documented disposition actions for each did not suggest the likely release of non-conforming product.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up." h2: checked follow-up type.H3: changed "no" to "yes." h6: entered evaluation codes.H10: added manufacturer narrative.

• Brand Name: IMP,TSV,6.0,8,MTX,MG
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19611687
• Report Number: 0002023141-2024-02127
• Device Sequence Number: 15029036
• Product Code: DZE
• UDI-Device Identifier: 00889024019911
• UDI-Public: (01)00889024019911(17)260131(10)1241829
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: 01/30/2026
• Device Catalogue Number: TSVT6B8
• Device Lot Number: 1241829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic