SIGMA 94-0014Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295223405), received between Apr 26, 2018 and Sep 12, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SIGMA 4X12.5 CR POLY AND SIGMA CR SIZE 4 LEFT FEMUR WERE EXPLANTED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23040665 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (LEFT KNEE) TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 19231786 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPERATIVE NOTES RECEIVED. ON (B)(6) 2023, THE PATIENT HAD A LEFT HYBRID TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE, LEFT KNEE. DEPUY COMPONENTS WERE IMPLANTED, INCLUDING DEPUY PATELLA, AND DEPUY CEMENT.

  Patient problems: Pain

  MAUDE report 18959995 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR MEDIAL PAIN OVER THE FAT PAD. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6), 2021. DATE OF EVENT: 29 NOV 2023. (LEFT KNEE). TREATMENT: EXPLORATION AND POSSIBLE EXCISION OF PARTIAL FAT PAD.

  Patient problems: Pain

  MAUDE report 18300635 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DIFFICULTY WALKING; EXTENSOR MECHANISM INSUFFICIENCY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: EXTENSOR MECHANISM RECONSTRUCTION.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16150085 ↗
• InjuryJun 3, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SCAR TISSUE UNDER THE QUADRICEPS TENDON - FEELINGS OF POPPING AND CREPITUS WITHIN THE KNEE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE) TREATMENT: ARTHROSCOPY.

  Patient problems: Adhesion(s); Pain; Unspecified Musculoskeletal problem

  MAUDE report 14591267 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AND OPERATIVE NOTES REVIEWED: ON (B)(6) 2021, PATIENT RECEIVED A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS END-STAGE OSTEOARTHRITIS. THE PATIENT RECEIVED J&J SIGMA PRESS-FIT FEMUR AND CEMENTED PATELLA AND TIBIAL TRAY COMPONENTS, WITH CR RP TIBIAL INSERT ARTICULATION. DEPUY BONE CEMENT WAS UTILIZED. THE PROCEDURE HAD NO REPORTED COMPLICATIONS. ON (B)(6) 2021, PATIENT WAS TREATED WITH A LEFT KNEE MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS. PRIOR TO THE PROCEDURE, HE ONLY HAD ABOUT 95 DEGREES OF FLEXION, WITH SIGNIFICANT STIFFNESS. FOLLOWING THE MANIPULATION, THE PATIENT WAS ABLE TO FLEX BETWEEN 115-120 DEGREES. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity

  MAUDE report 12481516 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: REVISED DUE TO PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 12466729 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT DISCOMFORT IN BOTH KNEES. POSTERIOR STIFFNESS AND PAIN. PAIN IS BILATERAL BUT WORSE IN THE LEFT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: LEFT KNEE WAS ASPIRATED AND SENT FOR SYNVASURE TO RULE OUT INFECTION. NO ARTHROFIBROSIS NOTED. LEFT KNEE IS STABLE. NO TREATMENT REPORTED FOR THE RIGHT SIDE.

  Patient problems: Discomfort; Muscular Rigidity; Pain

  MAUDE report 11334332 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INSTABILITY DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION: (B)(6) 2020; (LEFT KNEE). TREATMENT: REVISION OF FEMUR AND TIBIAL INSERT COMPONENTS; TIBIAL TRAY AND PATELLA WERE RETAINED.

  Patient problems: No Code Available

  MAUDE report 10791935 ↗
• MalfunctionMar 26, 2020Incorrect Measurement; Defective Device; Incorrect Measurement; Defective Device

  ADDITIONAL INFORMATION RECEIVED. SURGERY DELAY ABOUT 20 MINUTES.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9885453 ↗
• MalfunctionMar 19, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE POROCOAT FEMORAL COMPONENT DID NOT SIT FLUSH ON THE DISTAL FEMUR WHEN THE SURGEON TRIED TO INSERT IT. THE BONE WAS PREPARED ACCORDING TO SPECIFIED SIGMA SURGICAL TECHNIQUE. THE ANTERIOR AND POSTERIOR FLANGES MADE CONTACT, BUT THE DISTAL FEMUR HAD A GAP OF APPROXIMATELY 1-2MM. THE SURGEON STATED THAT HE BELIEVE THE FEMUR TO BE MANUFACTURED INCORRECTLY, DUE TO THE FACT THAT THE TRIALS FIT PERFECTLY AND THE IMPLANTS DID NOT. THE FEMUR WAS THEN PULLED BACK OUT AND A CEMENTED FEMUR WAS IMPLANTED SUCCESSFULLY. SURGICAL DELAY OF 4 MINUTES. DOE: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9856132 ↗
• InjuryApr 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF FEMORAL COMPONENT AT THE IMPLANT TO BONE INTERFACE. IT WAS ALSO STATED LOOSENING OF TIBIA AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN DEPUY CEMENT MANUFACTURER. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7464855 ↗