MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US P.F.C. SIGMA; SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY

Catalog Number	960908
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Muscular Rigidity (1968); Pain (1994); Joint Laxity (4526)
Date of Event	01/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2016: male patient received a right knee revision of an unk tka to treat stiffness, arthrofibrosis, and pain.The patient received a depuy tc3 including a femoral sleeve, femoral adaptor and bolt, hinged femoral component, hinged tibial insert, mbt tibial tray, tibial sleeve, and tibial stem.The unknown patella was retained.Unk cement was utilized.The procedure was completed without complications.On (b)(6) 2016: the male patient received an mua, non-depuy aspiration, and intraarticular injection to treat pain, swelling, stiffness, and arthrofibrosis s/p tc3 implantation.No infection was detected and rom restored to normal limits.On (b)(6) 2025: patient presents to urgent care with sudden onset right knee pain and instability.X-ray identified heterotopic ossification along the quadriceps tendon.Aspiration attempted to test for infection but was unsuccessful.Blood tests determined no bacterial or fungal infection present.On (b)(6) 2026: 56-year-old male patient receives a right knee revision to treat worsening pain, arthrofibrosis, instability, and stiffness.Upon entering the joint, the surgeon identified and debrided the arthrofibrosis and heterotopic ossification.The femoral component was loose at an unknown interface.The femoral bolt and adaptor were broken and the adaptor was stuck in the femoral sleeve, requiring femoral sleeve revision.The femur fractured while removing the sleeve.There was no reported product problem with the revised femoral stem.The patella was well-fixed but revised.There was no reported product problem with the revised tibial insert or the revised femoral stem.The tibial tray, sleeve, and stem were retained.The femur fracture was treated with cabling.The patient received a tc3 femoral construct with a femoral stem, a sigma insert and patella, and competitor cement.The procedure was completed without complications.Doi: (b)(6) 2016 doe: 03 november 2016 dor: (b)(6) 2026 affected side: right knee.
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.Investigation summary no device associated with this report was received for examination.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 1) quantity manufactured: (b)(4) 2) date of manufacture: 22-apr-2016 3) any anomalies or deviations identified in dhr: no non-conformances / manufacturing irregularities were identified.4) expiry date: 31-mar-2026 no non-conformances / manufacturing irregularities were identified.

• Brand Name: P.F.C. SIGMA
• Common Device Name: SIGMA REVISION IMPLANT : KNEE FEMORAL ACCESSORY
• 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: 25716338
• Report Number: 1818910-2026-11416
• Device Sequence Number: 5094573
• Product Code: JWH
• UDI-Device Identifier: 10603295234517
• UDI-Public: (01)10603295234517(17)260331(10)C19688
• 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 Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03/31/2026
• Device Catalogue Number: 960908
• Device Lot Number: C19688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2016
• 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 Age: 56 YR
• Patient Sex: Male