SIGMA 94-0028Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295223528), received between Feb 14, 2020 and May 2, 2024 — classified as 7 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 25 APR 2024. (RIGHT KNEE). TREATMENT: I&D.

  Patient problems: Unspecified Infection

  MAUDE report 19228719 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS . EVENT IS 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) 2023. (RIGHT KNEE). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Muscular Rigidity

  MAUDE report 18160084 ↗
• InjurySep 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE REVISION FOR PAIN DUE TO IMPLANTS OVERSIZE. CEMENT NOT FROM DEPUY. DOI: (B)(6) 2009; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15410573 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE NOTE (B)(6) 2022 INDICATE THE PATIENT HAD BEEN EXPERIENCING SOME POST OPERATIVE WOUND BLEEDING AND DRAINAGE WITH SLIGHT SKIN EXCORIATION AND NECROSIS THAT HAD BEEN TREATED WITH A WOUND VAC. THE WOUND DOES SHOW SIGNS ON IMPROVEMENT IN OFFICE. SHE IS ON IV ANTIBIOTICS AND THE WOUND VAC WAS EXCHANGED. SHE IS ALSO IN A KNEE IMMOBILIZER FOR THE TIME BEING.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding; Necrosis; Pocket Erosion; Swelling/ Edema

  MAUDE report 15216500 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12780017 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR INFECTION 11 YEAR POST OP. INFECTION ENTRY INTO SITE DUE TO OTHER CAUSES (ANOTHER OPERATION IN OTHER PART OF BODY).

  Patient problems: Unspecified Infection

  MAUDE report 12715420 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO A POSTERIOR STABILIZED FEMUR AND PS RP POLY DUE TO A LAX PCL LIGAMENT AND INSTABILITY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9711907 ↗