SIGMA 96-2353Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295242376), received between Jul 6, 2017 and Apr 24, 2026 — classified as 39 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DEVICE WAS IMPLANTED APPROXIMATELY 7 YEARS AGO. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 24984866 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INSTABILITY. DOI: (B)(6) 2013; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19118418 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN UNDISCOVERED NICKEL ALLERGY. THEY HAD PAIN THROUGHOUT THEIR LEG, SO THE SURGEON REPLACED EVERYTHING WITH COMPETITOR IMPLANTS. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 18184717 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH WASH OUT AND POLY EXCHANGE. DOI: UNKNOWN.DOR: (B)(6) 2023.AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17994542 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TIGHT IN FLEXION AS WELL AS EXTENSION FROM PREVIOUS SURGERY. NO INFECTION PRESENT. SURGEON WENT DOWN IN SIZE DUE TO TIGHTNESS IN THE POLY IMPLANT. DOI: (B)(6), 2023, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17842185 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND DEVELOPED AN INFECTION. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 16663181 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY SWAP AND WASH OUT WERE PERFORMED DUE TO INFECTION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16632885 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. REMOVAL OF POLY, WASHED OUT AND REPLACED WITH A NEW POLY. NOTHING MORE TO REPORT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16350484 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO BILATERAL INFECTIONS. SURGEON WASHED IT OUT AND REPLACED THE POLY IN BOTH KNEES. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16157689 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFLAMMATION AND SORENESS (REDNESS) AND SURGERY SCHEDULED FOR I AND D WITH POTENTIAL POLY SWAP. SURGERY SUCCESSFUL WITH POLY SWAP. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Erythema; Inflammation

  MAUDE report 16101827 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT I AND D WITH POLY EXCHANGE DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15995829 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON STATED PATIENT WAS UNSTABLE. THE SURGEON REMOVED THE FEMORAL COMPONENTS/POLY AND REPLACED FEMORAL COMPONENTS/POLY. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15909178 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14399765 ↗
• MalfunctionMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WENT TO THE DOCTOR WITH KNEE PAIN AFTER 6 YEARS OF KNEE REVISION. WHEN THE DOCTOR REVISED X-RAY SAW THE BOLT FREE IN THE KNEE. SHE DECIDED TO DO A NEW REVISION KNEE. YESTERDAY THE FEMORAL ADAPTER APPEARED BROKEN INTO THE PATIENT.

  Patient problems: Pain

  MAUDE report 13928148 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN. DOI: (B)(6) 2020. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12843970 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2005; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12813653 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12360042 ↗
• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT WAS CREATED IN ORDER TO CAPTURE A REPORTED EVENT REPORTING THAT THE PATIENT HAD A PREVIOUS REVISION OF POLY INSERT DUE TO INFECTION. DOI: (B)(6), 2019. DOR: (B)(6) 2019. RIGHT KNEE.

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

  MAUDE report 11969062 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO DELAYS DURING SURGERY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11793742 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND POLY EXCHANGE WERE DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 11640938 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). THE PATIENT WAS REVISED TO ADDRESS INFECTION. DATE OF IMPLANT: (B)(6) 2016, DATE OF REVISION: (B)(6) 2016 (INSERT ONLY), (LEFT KNEE). DEPUY COMPONENTS:.

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

  MAUDE report 11594515 ↗
• InjurySep 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MID FLEXION INSTABILITY. THE SURGEON INCREASED POLY SIZE FROM A SIZE 4 15MM TC3 TO A 17.5MM TC3 AND EVALUATE GAPPING. AFTER 15MM POLY WAS EXPLANTED AND BEGAN TRIALING WITH 17.5MM. AFTER FURTHER EVALUATION, THE SURGEON TRIALED 20MM POLY AND FOUND AND HAD FULL EXTENSION AND WAS SATISFIED WITH HIS FLEXION GAP 20MM. TC3 POLY WAS IMPLANTED. ORIGINAL IMPLANT DATE IS UNKNOWN. NO SURGICAL DELAY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10586650 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. WASHED OUT THE KNEE AND SWAPPED POLY. NO INDICATION OF ANY FAULT BY THE PRODUCT. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10174141 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A 2ND RIGHT KNEE REVISION DUE TO LOOSENING OF THE FEMORAL COMPONENT, CHRONIC MEDIAL FEMORAL CONDYLAR FRACTURE, AND MALROTATION OF THE TIBIAL COMPONENT. THE SURGEON NOTED THE PATIENT¿S KNEE GAVE OUT IN (B)(6) 2018, CAUSING A FALL. THE SURGEON REPORTED A MEDIAL FEMORAL CONDYLAR FRACTURE WITH SCLEROSIS AND FIBROUS TISSUE IN THE AREA. HE NOTED THE FEMORAL COMPONENT WAS LOOSE, AND FIBROUS TISSUE SURROUNDED THE SLEEVE, AND WAS EXCISED. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS WELL-FIXED. THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED. HE INDICATED THE PATELLAR TRACKING WAS REASONABLE, AND WAS RETAINED. THE PATIENT WAS IMPLANTED WITH DEPUY COMPONENTS AND COMPETITOR BONE CEMENT.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9418443 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP AND WASHOUT PERFORMED. NOTHING FURTHER TO REPORT. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9082052 ↗