SIGMA 1960-40-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295075066), received between Jun 21, 2018 and Jan 3, 2024 — classified as 14 injuries, 2 malfunctions.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMUR, TIBIAL AND PATELLA COMPONENTS BETWEEN CEMENT AND IMPLANT. THE CEMENT MANUFACTURER IS UNKNOWN. US-FDA MDR REPORTABILITY DETERMINATION: KNEE WAS REVISED TO ADDRESS IMPLANT LOOSENING OF THE TIBIAL TRAY, FEMUR, AND PATELLA IMPLANTS, AT THE CEMENT TO IMPLANT INTERFACE IN ALL THREE INSTANCES. IT IS REASONABLE TO CONCLUDE THAT EACH OF THE LOOSE CAUSED/CONTRIBUTED TO EACH PRODUCTS LOOSENING ALONE, AS THE INTEGRITY AND DURABILITY OF THOSE INTERFACES WITH CEMENT IS A PROPERTY INHERENT TO THE DESIGN OF EACH PRODUCT--OTHER IMPLANTS PLAY NO ROLE IN THE MAINTENANCE OF EACH IMPLANTS CEMENT BONDING INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18435992 ↗
• InjuryApr 26, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. TWO DEPUY CEMENTS WERE USED. DOI: (B)(6) 2009. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16815755 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE SURGERY WAS DONE 1 YEAR AGO, (B)(6) 2021. SENT FOR MEDICAL RECORDS, PHYSICAL THERAPY 35 TIMES AND THEN 22 MORE SESSIONS (57 TOTAL). REVISION KNEE SURGERY REQUIRED, LOOSE LIGAMENTS, DEPUY CEMENT. SHE CALLED THE REPORTER AS THE REPORTER WAS LISTED ON A RECALL SHE FOUND ONLINE. THE REPORTER HAS CALLED HER A FEW TIMES AND SHE HAS CALLED THE REPORTER A FEW TIMES. THEY JUST CONNECTED. DOI: (B)(6) 2021; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15300048 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INSTABILITY. DATE OF IMPLANT: (B)(6) 2008, DATE OF REVISION: (B)(6) 2022, RIGHT KNEE. FEMORAL COMPONENT, TIBIAL BASE, AND INSERT WERE REMOVED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 14955679 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 23 JUL 2021. PATIENT HAD A UNKNOWN DEPUY SIGMA SYSTEM IMPLANTED. ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED, PATELLA WAS RESURFACED, AND UNKNOWN CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS INFECTION. AT EVALUATION VISITS PRIOR TO REVISION, THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE SURGEON NOTED SYNOVITIS, SOFTENING OF THE BONE, AND A SMALL ABSCESS IN THE PATELLA THAT WAS DEBRIDED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THERE IS NO EVIDENCE THE PATELLAR COMPONENT WAS REVISED. THE SURGEON PLACED AN ANTIBIOTIC SPACER AND THE PATIENT RECEIVED IV ANTIBIOTICS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12336155 ↗
• MalfunctionJul 6, 2021Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT UPON OPENING THE NEW STERILE IMPLANT, THE PACKAGING MATERIAL ADHERED TO IMPLANT. THE HOSPITAL STAFF WERE UNSUCCESSFUL AT REMOVING THE PACKAGING MATERIAL FROM THE IMPLANT. THE SURGEON ELECTED TO OPEN ANOTHER NEW STERILE IMPLANT TO USE. THE INVOLVED IMPLANT WAS THEN TERMINALLY STERILIZED, RESULTING IN THE PACKAGE MATERIAL BEING REMOVED INADVERTENTLY. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED WITHIN THIS SUBMISSION. DOE: (B)(6) 2021. LEFT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12120924 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED LEFT KNEE. REMOVAL OF IMPLANTS AND INSERTION OF CEMENT SPACER PERFORMED. NO LOOSENING REPORTED. NO DELAY DURING SURGERY. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11821172 ↗
• MalfunctionMar 24, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SIGMA 4N FEMUR CAME OUT OF THE PACKAGE WITH FOAM FROM THE PACKAGING STUCK TO THE FEMORAL CONDYLE AND THE SURGEON REJECTED THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562777 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 10754851 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY: (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS PERIPROSTHETIC BONE FRACTURE AND FAILED TOTAL KNEE REPLACEMENT. DATE OF IMPLANTATION: (B)(6) 2012, DATE OF REVISION: (B)(6) 2014, (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, AND TIBIAL INSERT WERE REVISED; PATELLA RETAINED.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10673742 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10483192 ↗
• InjuryMay 8, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT WAS REVISED TO ADDRESS INSTABILITY WITH FEMORAL COMPONENT, OVERSIZED. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8591063 ↗
• InjuryMar 11, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2010; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8408963 ↗
• InjuryJan 24, 2019Noise, Audible; Noise, Audible

  CLINICAL ADVERSE EVENT RECEIVED FOR PATELLA CLUNK.

  Patient problems: No Consequences Or Impact To Patient; Pain; Scarring

  MAUDE report 8274056 ↗
• InjuryNov 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8101680 ↗
• InjuryJun 21, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF FEMUR AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT MANUFACTURER. DOI: (B)(6) 2013 DOR: (B)(6) 2018 LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7625056 ↗