SIGMA 1960-40-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295075080), received between Nov 29, 2017 and Aug 1, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Adverse 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 LOOSENING OF THE TC3 TIBIA W/ STEM AND SLEEVE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT¿S KNEE BECAME SEPTIC AND TIBIAL CONSTRUCT BECAME LOOSE. THE FEMUR, TIBIAL CONSTRUCT, POLY, AND PATELLA WERE EXTRACTED. PATELLA WAS NOT LISTED IN THE LIST OF IMPLANTS FROM INITIAL SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22687554 ↗
• InjuryOct 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. CEMENT MANUFACTURER IS DEPUY. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17944335 ↗
• InjuryAug 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO KNEE PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNE.

  Patient problems: Pain

  MAUDE report 17487038 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS FROM (B)(6) 2020 NOTE THAT THE PATIENT WENT THE ER DUE TO WORSENING LEFT KNEE PAIN AND GOT AN INJECTION OF TORADOL. DOI: (B)(6) 2016. DOR: (B)(6) 2017 (CAPTURED IN (B)(4)). DOE: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10582951 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION KNEE SURGERY REQUIRED FOR PAINFUL TOTAL KNEE PROSTHESIS. SURGEON WAS GOING TO PERFORM A PATELLA RESURFACING AS PRIMARY PLAN, HOWEVER A LARGE FEMORAL CYST WAS DETECTED AS WELL AS A POTENTIALLY LOOSE TIBIAL TRAY, SO AN ENTIRE KNEE REVISION WAS PERFORMED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES.

  Patient problems: Cyst(s); No Code Available; Not Applicable; Pain

  MAUDE report 9356062 ↗
• InjuryJun 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2011. DOR: MAY 21, 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8682414 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE REMOVED AND COMPETITOR ANTIBIOTIC SPACER WAS IMPLANTED. DOI: (B)(6) 2019; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8647025 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTED LEFT KNEE JOINT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8151633 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED KNEE JOINT. PATIENT CONSEQUENCE? UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7628953 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS A DRAINING SINUS AND WAS BROUGHT TO OR FOR I&D VS. REVISION. IT WAS CONFIRMED THAT THE TRACT WENT UNTO THE JOINT. IT WAS ALSO REPORTED THAT ALL COMPONENTS WERE REMOVED AND A ONE STAGE REVISION WAS PERFORMED. FROZEN SECTION WAS PERFORMED AND INFECTION WAS CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 7066783 ↗