MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 4 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158114010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6 investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection revealed signs of the device being implanted for a long period of time (around 13 years).Additionally to the eccentric wear observed, one of the condyles surface was found deformed, most probably due to an abnormal weight loading over one side of the condyle or as a component failure led by the fracture on the femoral component.However, consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.With information provided, the complained adverse event cannot be confirmed.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.A manufacturing record evaluation were performed for the finished device dhr 158114010/ d11091281, it was manufactured on 22-sep-2011.45 parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.The overall complaint was not confirmed as the observed condition of the sigma crvd gvf ins 4 10mm would have not contributed to the complained adverse event.¿ based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot 1) quantity manufactured: 45 2) date of manufacture: 22-sep-2011 3) any anomalies or deviations identified in dhr: no 4) expiry date: 25-sep-2016 5) ifu reference: ifu-0902-00-252 device history review manufacturing record evaluation were performed for the finished device dhr 158114010/ d11091281, it was manufactured on 22-sep-2011.45 parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that there was a revision of knee-tep left side because pain.X-ray and ct findings unclear.During revision fracture of posterior lateral femoral condyle was obvious.

• Brand Name: SIGMA CRVD GVF INS 4 10MM
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21169103
• Report Number: 1818910-2025-01038
• Device Sequence Number: 4336423
• Product Code: JWH
• UDI-Device Identifier: 10603295063452
• UDI-Public: (01)10603295063452(17)160925(10)D11091281
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 01/16/2025

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 Expiration Date: 09/25/2016
• Device Catalogue Number: 158114010
• Device Lot Number: D11091281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2011
• 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
• Patient Sequence Number: 1
• Patient Sex: Male