MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 2 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158111008
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Pfc sigma poly is not getting locked on metal tibia base.There was no surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.A manufacturing record evaluation were performed for the finished device dhr 158111008 / d24062994.It was manufactured on 03-jul-2024.Total 48 parts were manufactured per specification and all raw materials met specification.After searching " d24062994" in etq, no record is displayed.After searching "sigma cvd gvf insert" in etq, all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching "d24062994" in sap by zqmr1023, no internal lock record is displayed.Hereby drawing a conclusion that no non-conformances were identified for this batch of products.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot- a manufacturing record evaluation were performed for the finished device dhr 158111008 / d24062994.It was manufactured on 03-jul-2024.Total 48 parts were manufactured per specification and all raw materials met specification.After searching " d24062994" in etq, no record is displayed.After searching "sigma cvd gvf insert" in etq, all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching "d24062994" in sap by zqmr1023, no internal lock record is displayed.Hereby drawing a conclusion that no non-conformances were identified for this batch of products.Device history review- a manufacturing record evaluation was performed for the finished device, and no non-conformances / manufacturing irregularities related to the malfunction were identified.

• Brand Name: SIGMA CRVD GVF INS 2 8MM
• Common Device Name: SIGMA KNEE PRIMARY : 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: 22124374
• Report Number: 1818910-2025-08856
• Device Sequence Number: 7273980
• Product Code: JWH
• UDI-Device Identifier: 10603295063087
• UDI-Public: (01)10603295063087(17)20290630(10)D24062994
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K033272
• 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

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: 158111008
• Device Lot Number: D24062994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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
• Patient Sex: Unknown