SIGMA 1960-64-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295075301), received between Oct 6, 2017 and Mar 8, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. NO DELAYS.

  Patient problems: Unspecified Infection

  MAUDE report 18867260 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT KNEE WAS REVISED DUE TO SIGNIFICANT FLEXION CONTRACTURE. THE FEMORAL COMPONENT ONLY WAS REVISED TO RAISE THE JOINT LINE. TIBIAL COMPONENTS WERE LEFT IN SITU. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Contracture

  MAUDE report 12915901 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED KNEE. SURGEON REMOVED ALL COMPONENTS AND PUT IN CEMENT SPACER. DOI: (B)(6) 2019 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10222640 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FALL CAUSING DAMAGE AND INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9557817 ↗
• InjuryOct 18, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS SIGNIFICANT LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 7977119 ↗
• InjuryOct 6, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED (B)(6) 2017. REVISION DUE TO PAIN, GRINDING/POPPING SENSATION, PERSISTENT SWELLING AND LIMITED MOBILITY WITH ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS - CEMENT TO IMPLANT INTERFACE. ON (B)(6) 2017 MEDICAL RECORDS AND CLAIM LETTER REVIEWED. PRIMARY OPERATIVE NOTES (B)(6) 2012 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY DUE TO DEGENERATIVE JOINT DISEASE OF THE LEFT KNEE. PROCEDURE WAS COMPLETED WITHOUT COMPLICATION NOTED. POST-OP X-RAY REVEALS A WELL SEATED LEFT KNEE ARTHROPLASTY WITH NO FRACTURES OR DISLOCATIONS. OFFICE NOTES (B)(6) 2015 INDICATE THE PATIENT PRESENTS WITH PAIN, GRINDING/POPPING SENSATION, SWELLING AND LIMITED MOBILITY. BONE SCAN RESULTS SHOW SIGNS OF IMPLANT LOOSENING. REVISION OPERATIVE NOTES (B)(6) 2015 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY REVISION DUE TO LEFT KNEE PAIN, PERSISTENT SWELLING AND LIMITED MOBILITY WITH ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS. PATHOLOGY FINDINGS FROM SUBMITTED INTRA-OP SPECIMEN JOINT FLUID REVEALED NO SIGNS OF ACUTE INFLAMMATION, GRAM STAIN SHOWS RARE WBC, NO ORGANISMS SEEN. PROCEDURE DETAIL INDICATES THAT THE PATELLA WAS QUITE STABLE. THE FE

  Patient problems: Joint Swelling; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6921994 ↗