SIGMA 96-2346Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295242277), received between Nov 4, 2019 and Nov 6, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT REVISION DUE TO PAIN. PATIENT'S FEMORAL COMPONENT WAS FOUND TO BE SLIGHTLY LOOSE SO IT WAS REMOVED AND REPLACED WITH ANOTHER FEMORAL COMPONENT OF THE SAME SIZE. THE LOOSENING INTERFACE WAS AT THE BONE TO CEMENT. CEMENT MANUFACTURER IS UNKNOWN. THE POLY INSERT WAS ALSO REPLACED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18074892 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION (STAPH EPPI), I&D AND POLY EXCHANGE PERFORMED. NO SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12569490 ↗
• InjuryAug 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION OF TOTAL LEFT KNEE REPLACEMENT ON SEPSIS AND LOOSENING. FRACTURE / LOOSENING OF THE FEMORAL BOLT SCREW. CONSEQUENCE ON THE PATIENT: PAIN +++, NO DEBRIS, DISPLACEMENT OF THE FEMUR. DOI: (B)(6) 2019; DOR: UNKNOWN; LEFT KNEE.

  Patient problems: Joint Dislocation; Pain; Sepsis

  MAUDE report 12357962 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF INFECTION SO A POLY EXCHANGE OF THE TIBIAL INSERT 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 11974153 ↗
• InjuryMar 5, 2021Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGERY WAS NOT EXTENDED. THE INSERT WAS STILL IN THE TRAY AND DID NOT SPIN 90 DEGREES. THE FEMUR DISLOCATED DUE TO SOFT TISSUE INJURY.

  Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 11424240 ↗
• InjurySep 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATED KNEE DUE TO FALL. SURGEON OPTED TO GO WITH A THICKER POLY. ALL COMPONENTS WERE FOUND TO BE SOLID AND IN GOOD ALIGNMENT. DOI: (B)(6) 2020. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: Fall; Joint Dislocation; No Code Available

  MAUDE report 10543302 ↗
• InjuryJul 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS END-OF-STEM PAIN. ALL COMPONENTS WERE REMOVED AND REVISED TO OTHER REVISION KNEE SYSTEM. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10275930 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10154115 ↗
• InjuryNov 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE POLY EXCHANGE DUE TO INFECTION. THE SURGEON REPORTED PURULENT MATERIAL UPON ENTERING THE KNEE. HE REPORTED DEBRIDEMENT AND REMOVAL OF ALL NECROTIC MATERIAL. THE SURGEON NOTED THE EXCHANGE OF THE POLY INSERT. HE DID NOT COMMENT ON THE OTHER COMPONENTS, AND THEY WERE NOT REVISED. DEPUY POLYETHYLENE INSERT WAS IMPLANTED IN THE PROCEDURE AND THERE WERE NO COMPLICATIONS. DOI: (B)(6) 2014; (TIBIAL, FEMORAL, PATELLAR COMPONENTS). DOI: (B)(6) 2017; (TIBIAL, FEMORAL, PATELLAR COMPONENTS. DOR: (B)(6) 2017; (POLYETHYLENE INSERT).

  Patient problems: Necrosis; No Code Available; Unspecified Infection

  MAUDE report 9274945 ↗