MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA; EARLY INTERVENTION : KNEE TIBIAL INSERT

Catalog Number	102453508
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
In the end surgery, they tried to install the insert and it didn't grasp on the tray after several attempts.They took a new insert and achieved the same result.Then they took a slightly higher 1 mm because they didn¿t have more in stock.The same result was achieved.They struggled with the fourth insert and they got it in place.

• Brand Name: SIGMA
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 25112341
• Report Number: 1818910-2026-08445
• Device Sequence Number: 13332124
• Product Code: NPJ
• UDI-Device Identifier: 10603295002642
• UDI-Public: (01)10603295002642(17)300331(10)M8929F
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K233980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 102453508
• Device Lot Number: M8929F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 07/21/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/09/2026; 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SIGMA HP UNI INS SZ5 7MM LM/RL; SIGMA HP UNI INS SZ5 7MM LM/RL
• Patient Sex: Unknown