MAUDE Adverse Event Report: DePuy Orthopaedics Inc US SIGMA; Sigma Revision Implant : Knee Tibial Insert

Catalog Number	962361
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Thayer school of engineering at dartmouth first report of retrievals for statement of work 10 for q2 of 2026.Darthmouth is the research location, and not the facility of placement.A depuy synthes implant was revised and reviewed for analysis.Reason for revision: revision due to infection.The non-articular surface of the mobile-bearing polyethylene tibial insert shows minor yellowing.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: this device is a peripheral of the velys hip navigation system distributed by depuy synthes joint reconstruction as a non-medical device.The product is designed, manufactured, and labeled by the legal manufacturer supplier.No further investigation required as this device is distributed as a non-medical device.Additional complaint information monitoring for potential signals will be conducted through complaint trending as part of post market surveillance.Device history lot no dhr or mre is needed for peripherals.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA
• Common Device Name: Sigma Revision Implant : Knee Tibial Insert
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50168311
• Report Number: 1818910-2026-13505
• Device Sequence Number: 5278864
• Product Code: NJL
• UDI-Device Identifier: 10603295242482
• UDI-Public: (01)10603295242482(17)200531(10)670465
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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: 05/31/2020
• Device Catalogue Number: 962361
• Device Lot Number: 670465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 08/07/2026
• Initial Report FDA Received Date: 08/06/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2015
• 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 Sex: Unknown