MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA TC3 FEM LEFT SZ4; SIGMA REVISION IMPLANT : KNEE FEMORAL

Catalog Number	960083
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limb Fracture (4518); Bone Notching (4890)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 there was a fracture in the left knee.A revision procedure took place on (b)(6) 2025.It was noted the bone behind the femoral component was in a very bad condition, there was no bony support for the metal component.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint recon described in this report.H11 additional narrative: added: a1, a3a, h6.Health effect - clinical code.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "hcp is reporing a fracture in the left knee-tep.See x-rays.Revision is planned".The product was not returned to depuy synthes; however, an x-ray and photos were provided for review.(b)(4) implant passport and (b)(4) x-rays.Review of the available evidence determined that the pfc*sigma tc3 fem left sz4 does not exhibit any damage or signs of a device non-conformance that could have contributed to the reported event.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was not confirmed as the observed condition of the pfc*sigma tc3 fem left sz4 would not have contributed to the reported 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 depuy synthes 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: (b)(4) pcs total manufactured.2) date of manufacture: 03-08-2011.3) any anomalies or deviations identified in dhr: an internal nr was found, however is not related with the reported condition.4) expiry date: 03-05-2021.5) ifu reference: ifu-0902-00-252.Device history review: a manufacturing record evaluation was performed for the finished device product code 960083 lot number fh5dj4, and no non-conformances / manufacturing irregularities were identified during manufacturing.Added: d10 (concomitant).
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL
• 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: 23717502
• Report Number: 1818910-2025-21218
• Device Sequence Number: 15698716
• Product Code: JWH
• UDI-Device Identifier: 10603295232506
• UDI-Public: (01)10603295232506(17)210305(10)FH5DJ4
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K952830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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: 03/05/2021
• Device Catalogue Number: 960083
• Device Lot Number: FH5DJ4
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 02/12/2026; 05/13/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/26/2025; 02/13/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2011
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 4.; SIG FEM ADAP +2/-2 OFFSET BOLT.; UNIVERSAL STEM 115X16MM FLUTED.; UNIVERSAL STEM 115X16MM FLUTED.; UNK KNEE FEMORAL ADAPTOR.; UNK KNEE FEMORAL SLEEVE.; UNKNOWN KNEE TIBIAL INSERT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 264 LB