SIGMA 97-0461Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295250616), received between Mar 21, 2018 and May 5, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2015, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21962210 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY PATIENT CONSEQUENCE RELATED TO THE EVENT? ¿ NO PRIMARY PATELLA AT THE TIME OF PRIMARY SURGERY. THE PATELLA REQUIRED ARTHROPLASTY. B. REASON FOR REVISION. ¿ PATELLA ARTHROPLASTY.

  Patient problems: Insufficient Information

  MAUDE report 18968916 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17774482 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. IRRIGATION AND DEBRIDEMENT (I&D) WAS CARRIED OUT AND POLY SWAP WAS PERFORMED. NO SURGICAL DELAY. DOI: (B)(6) 2013. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17395729 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT STATED THAT "I HAD BILATERAL KNEE REPLACEMENTS PERFORMED (B)(6), 2011 WITH SIGMA IMPLANTS. MY ORTHOPEDIC SURGEON IN BALTIMORE, MD SAID THE KNEES WOULD LAST 15-20 YEARS. HAVING SIGNIFICANT PAIN IN BOTH KNEES WHILE CYCLING PROMPTED A VISIT TO DR. ON (B)(6) 2021 WHERE HE INFORMED ME THAT THE HARDWARE HAS COME LOOSE INDICATING A REVISION IS NEEDED. THIS IS WELL SHORT OF THE 15-20 YEARS LIFESPAN OF THE SURGERY. I HAD A CYCLING GOAL TO DO RAAM (RACE ACROSS AMERICA) AND HAD TO CANCEL A QUALIFIER IN LATE AUGUST IN UTAH. I WAS HOPING TO BECOME THE FIRST 70+ YEAR OLD RIDER TO BE AN OFFICIAL FINISHER. NOW DUE TO REVISION IN THE KNEES, I'LL HAVE TO WAIT AT LEAST 2 YEARS.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 16536348 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. A WASHOUT WAS DONE AND THE POLY WAS EXCHANGED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15485167 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSE BODY, POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15418248 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. PATIENT HAD PRIMARY SURGERY DONE ABOUT 20 YEARS AGO. THE REASON FOR POLY EXCHANGE WAS INSTABILITY. NO SURGICAL DELAY. DOI: 20 YEARS AGO. DOR: JUL 11, 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15113070 ↗
• MalfunctionApr 21, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCT HAS BEEN USED IN THE HOSPITAL ON (B)(6) 2022. EXPIRATION DATE OF PRODUCT WAS (B)(6) 2022. PRODUCT WAS USED DURING JOINT RECONSTRUCTION. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171883 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECURRENT LACTOBACILLUS INFECTION. DOI: (B)(6) 2021; DOR: UNK; RIGHT KNEE.

  Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13203636 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND OPENED INCISION. WENT IN AND DID POLY EXCHANGE W I&D DOI: (B)(6) 2021 .DOR: (B)(6)2021. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 12853775 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 12413173 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFF KNEE. WENT FROM A 10MM POLY TO AN 8MM POLY. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 11999761 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. IT REQUIRES A REPLACEMENT TO A THICKER INSERT 15MM. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9202458 ↗
• InjuryMar 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGED DUE TO INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7359196 ↗