MAUDE Adverse Event Report: DePuy Orthopaedics Inc US P.F.C. SIGMA; Sigma Knee Primary : Knee Tibial Insert

Catalog Number	158121015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision of sigma implants, originally implanted approximately around 2010,occurred for loosening and significant subsequent subsidence resulting in the tibia breaching the cortical bone anteriorly.Implants were removed, minimal cemented was observed on the implants or bone.It was also mentioned that the surgeon who originally implanted these implanted using a fast set cement so setting time could have contributed to the lack of fixation.Loosening occurred on the tibial side.It is unknown whether this commenced from the cement to implant or cement to bone interface.Patella was not resurfaced.No surgical delay.Unknown patient status.
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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: P.F.C. SIGMA
• Common Device Name: Sigma Knee Primary : 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: 50122457
• Report Number: 1818910-2026-13241
• Device Sequence Number: 21452284
• Product Code: JWH
• UDI-Device Identifier: 10603295063957
• UDI-Public: (01)10603295063957(17)120508(10)BK7NE4000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2012
• Device Catalogue Number: 158121015
• Device Lot Number: BK7NE4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2007
• 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: Female