SIGMA 96-2345Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295242260), received between Oct 6, 2017 and Jan 8, 2026 — classified as 23 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RETURNED TO SURGERY FOR AN INFECTED TC3 REVISION KNEE. THE KNEE WAS WASHED OUT AND THE POLY SWAPPED. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24003206 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DEALING WITH AN ONGOING INFECTION. THE KNEE WAS WASHED OUT AND POLY EXCHANGED FOR THE SAME SIZE. THE OLD POLY WAS DESTROYED UPON EXTRACTION. THERE WAS NO HARM TO THE PATIENT, NOR DELAY TO THE CASE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22414980 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL RIGHT KNEE. SURGEON CONVERTED FROM A TC3 TO DISTAL FEMORAL REPLACEMENT. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21596950 ↗
• InjurySep 23, 2024Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PATIENT WAS REVISED DUE TO CHRONIC PAIN. PATIENT SEEN IN ED WITH DISLOCATED KNEE. CORRECTIVE SURGERY HAD MASSIVE METALOSIS, OSTEOLYSIS, AND POLYETHYLENE WEAR. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL: YES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Foreign Body Reaction; Joint Dislocation; Osteolysis; Pain

  MAUDE report 20279439 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO STIFFNESS. DOCTOR REMOVED AND REPLACED POLY INSERT. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18950828 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE. NO DELAY. DOI- (B)(6) 2020. DOR- (B)(6) 2023. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18118826 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INFECTION. THE SURGEON WASHED OUT AND EXCHANGED THE INSERT. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2012, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18073559 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED TOTAL KNEE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18046460 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP WAS PERFORMED DUE TO INSTABILITY. NO KNOWN INFECTION. NO KNOWN TRAUMA. NO SURGICAL DELAY. DOI- (B)(6) 2017. DOR- (B)(6) 2022. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14677185 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED THE KNEE BECAUSE THE PATIENT COMPLAINED OF SHIN PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2019. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12414021 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS A CONFIRMED INFECTION. A POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11690689 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE BECAME VERY STIFF. SURGEON REMOVED THE POLY AND DID A DEBRIDEMENT. POLY WAS DOWN SIZED. DOI: (B)(6) 2017 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 11259178 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10857465 ↗
• InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A UNSTABLE KNEE AND NEEDED A CONVERSION TO A HINGE KNEE. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10162639 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO ARTHRITIS. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND COMPETITOR BONE CEMENT. ON (B)(6) 2016, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO CHRONICALLY DISLOCATED PATELLAR COMPONENT SECONDARY TO MALPOSITION OF FEMORAL COMPONENT AND INTERNAL ROTATION. THE SURGEON REPORTED FEMORAL COMPONENT HAD SIGNIFICANT INTERNAL ROTATION. HE NOTED THE PATELLAR COMPONENT WAS IN APPROPRIATED POSITION, ALIGNMENT, AND WAS NOT LOOSE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION WITH POLY EXCHANGE DUE TO LAXITY, INSTABILITY, AND PAIN. THE SURGEON REPORTED THE FEMORAL, TIBIAL, AND PATELLAR COMPONENTS WERE WELL-FIXED AND RETAINED. HE INDICATED THE POLY WAS UPSIZED FOR IMPROVED EXTENSION AND FLEXION. THERE WERE NO COMPLICATIONS REPORTED. TWO DEPUY CEMENT PRODUCTS WERE USED DURING PRIMARY OPERATION. PLEASE ADD HOSPITAL ACCOUNT INFORMATION. AWA

  Patient problems: No Code Available; Pain

  MAUDE report 9497379 ↗
• InjuryAug 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. CONVERTED FROM TC3 TO HINGED DISTAL FEMUR. DOI: (B)(6) 2017; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8897919 ↗
• InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND EXCHANGE OF THE TIBIAL INSERT WAS PERFORMED. THE COMPONENTS WERE WELL FIXED. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 8334764 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT WAS REVISED TO ADDRESS AN INFECTION. I&D AND POLY EXCHANGE WERE PERFORMED. THE DATE OF THE INITIAL LEFT KNEE PROCEDURE IS UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8304151 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8154729 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8005821 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE DUE TO INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 7953220 ↗
• InjuryJul 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. LINER EXCHANGE WAS PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2018. UNKNOWN OPERATIVE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 7677228 ↗
• InjuryOct 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6922530 ↗