SIGMA 96-2356Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295242437), received between Sep 11, 2018 and Feb 24, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 24, 2026Fracture

  ADDITIONAL INFORMATION RECEIVED: A. DID IT BROKE INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY OF THE INSTRUMENT. IS IT BENT, CRACKED, STRIPPED, WORN OR CROSS THREADED? IT WAS BROKEN IN 2 PLACES. B. WERE THERE ANY FRAGMENTS GENERATED? IF YES, WERE ALL THE PIECES RETRIEVED? IT APPEARS THERE WERE SMALL FRAGMENTS. C. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? I CANNOT ASSUME THE INSTABILITY ISSUE. D. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? COMPONENTS WERE WELL FIXED AND APPEARED TO BE IN GOOD POSITION. E. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? COMPONENT SIZING SEEMED APPROPRIATE. F. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? THERE WAS NO PATELLA BAJA OR ALTA. G. CAN YOU PLEASE PROVIDE THE IMPLANT DATE? I DO NOT KNOW THE ORIGINAL IMPLANT DATE AS THIS SURGEON DID NOT IMPLANT THEM. PATIENT DID NOT HAVE THIS INFORMATION EITHER.

  Patient problems: Joint Laxity

  MAUDE report 24429508 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23427085 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED DUE TO PAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. DOI: UNK, DOR: (B)(6) 2025, AFFECTED AREA: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22079847 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17585318 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2016; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15586886 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2020, THE PATIENT UNDERWENT A RIGHT KNEE REVISION WITH TIBIAL INSERT EXCHANGE, IRRIGATION AND DEBRIDEMENT, AND PLACEMENT OF ANTIBIOTIC PELLET TO ADDRESS INFECTION. THE PATIENT WAS EXPERIENCING PAIN, SWELLING, WARMTH, AND INSTABILITY. THE SURGEON NOTED SYNOVITIS WITHIN THE OPERATIVE NOTE. THE TIBIAL TRAY, PATELLAR COMPONENT, AND FEMORAL COMPONENT WERE RETAINED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS.

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

  MAUDE report 11404699 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED ON 12 JUL 2019 WERE REVIEWED FOR MDR REPORTABILITY ON 2 OCT 2019. THE CLAIM SHEET INDICATES THE PATIENT UNDERWENT A SECOND LEFT KNEE REVISION DUE TO UNKNOWN REASONS ON (B)(6) 2019. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Muscle/Tendon Damage

  MAUDE report 10949776 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL TKA WAS AN INTERMEDICS DONE IN SALT LAKE CITY.

  Patient problems: Adhesion(s); Discomfort; Edema; No Code Available; Pain

  MAUDE report 10646425 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2012. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9829094 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT AN ARTICULAR INSERT EXCHANGE DUE TO WOUND INFECTION AND HEMATOMA. DEPUY TIBIAL INSERT WAS IMPLANTED IN THE PROCEDURE. NO COMPLICATIONS WERE REPORTED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 9211058 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. UNKNOWN ORIGINAL SURGERY DATE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019; UNKNOWN SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9071509 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2017. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8480072 ↗
• InjurySep 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INCISION AND DRAINAGE AND A POLY SWAP DUE TO INFECTION. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7864883 ↗