SIGMA 1960-40-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295075059), received between Oct 25, 2017 and Feb 19, 2026 — classified as 30 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC INSTABILITY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24387679 ↗
• InjuryMay 29, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PATIENT RETURNED TO SURGERY FOR ASEPTIC LOOSENING OF THE FEMUR IMPLANTS. THE FEMUR AND TIBIA WERE REMOVED AND AN ATTUNE REVISION WAS PLACED. NO INSERT CONCERNS, NO DELAYS, NO OTHER ADVERSE EVENTS OTHER THAN THE LOOSE FEMUR. THE TIBIA WAS REVISED DUE TO THE FEMORAL REVISION BEING DONE. DOI: (B)(6) 2014, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22108340 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL KNEE JOINT EXPLANT DUE TO KNEE JOINT INFECTION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20577418 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A PRIMARY KNEE AND EXPERIENCED POST CAR ACCIDENT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 17606972 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2017. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16952026 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY. THE CEMENT APPEARED TO BE GHV DEPUY CEMENT (JUDGING BY COLOR). THE PATELLA WAS RESURFACED, BUT THE COMPONENT WAS RETAINED.

  Patient problems: Osteolysis

  MAUDE report 16833527 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT¿S KNEE WAS REVISED DUE TO PAIN, PER SURGEON DISCRETION. TIBIA WAS SUSPECTED TO SHOW SOME SIGNS OF LOOSENING BUT NOTHING CONCRETE. DOI: UNKNOWN; DOR: UNKNOWN; UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15163691 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN IN HIS KNEE POST UPPER RESPIRATORY INFECTION. INCISION AND DRAINAGE WAS PERFORMED UNEVENTFULLY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13386046 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION LEFT TOTAL KNEE REPLACEMENT. PRIMARY KNEE DONE 12 MONTHS AGO ON (B)(6) 2020 WITH PFC FIXED BEARING CONSTRUCT. NO DEPUY CEMENT WAS USED IN PRIMARY CASE. IF OTHER, DESCRIBE: REVISION TOTAL KNEE REPLACEMENT LEFT KNEE, DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: CAIRNS PRIVATE HOSPITAL, WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: PAIN & INSTABILITY, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. ON (B)(6) 2021, REASON FOR REVISION SURGERY: PAIN & INSTABILITY OF LEFT KNEE, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN, INSTABILITY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: REVISION TOTAL KNEE SURGERY, IS THE PATIENT PART OF A CLI

  Patient problems: Joint Laxity; Pain

  MAUDE report 12470643 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED. DOI: UNKNOWN, DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12167656 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A SIGMA TOTAL KNEE DONE ON (B)(6) 2019 AND A REVISION OF TIBIAL COMPONENT ON (B)(6) 2020 (NO DER RECORD IN THE SYSTEM). THE PATIENT COMPLAINT OF PAIN AND INSTABILITY WITH KNEE "GIVING OUT". THE FEMORAL AND THE TIBIAL COMPONENTS WERE REMOVED AND AN ATTUNE REVISION WAS PERFORMED. DOI: (B)(6) 2019, 1ST REVISION: (B)(6) 2020 (TIBIAL COMPONENT), 2ND REVISION: (B)(6) 2021 (FEMORAL AND TIBIAL COMPONENTS), LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11680473 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF THE LEFT TOTAL KNEE TO ADDRESS INFECTION. DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: EXPLANTATION OF ALL IMPLANTS.

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

  MAUDE report 11251546 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BILATERAL KNEE REVISION DUE TO CONFIRMED INFECTION. IN ADDITION TO THE PREVIOUSLY REPORTED BILATERAL SWELLING, THE PATIENT WAS ALSO EXPERIENCING THE FOLLOWING BILATERAL KNEE ISSUES: PATELLA CLUNK, INSTABILITY, PAIN, DISCOMFORT, STIFFNESS, SYNOVITIS, EFFUSIONS, AND ADHESIONS. THE LEFT KNEE WAS NOTED TO SHOW OSTEOLYSIS UNDER THE PATELLA WHILE THE RIGHT KNEE SHOWED FEMORAL AND TIBIAL BONE LOSS.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11229911 ↗
• InjuryJan 25, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  ON (B)(6) 2017, THE PATIENT WAS NOTED TO HAVE A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS. DEPUY COMPONENTS INCLUDING DEPUY PATELLA AND DEPUY CEMENT WERE USED. THERE WERE NO COMPLICATIONS NOTED DURING THE PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD BILATERAL STAGE ONE REVISION TO ADDRESS BILATERAL CHRONICALLY INFECTED TOTAL KNEE ARTHROPLASTIES. PRIOR TO SURGERY THE PATIENT WAS NOTED TO HAVE PAIN, SWELLING, CHRONIC CLUNK, STIFFNESS, AND DISCOMFORT WITH SIGNIFICANT SYNOVITIS AND EFFUSION. GRAM-POSITIVE COCCI WERE FOUND DURING PREOPERATIVE ASPIRATION. ALL COMPONENTS INCLUDING THE PATELLA WERE REVISED. DEPUY COMPONENTS INCLUDING DEPUY CEMENT WERE USED DURING THIS PROCEDURE. ON THE RIGHT SIDE, THE SURGEON NOTED A LITTLE BIT MORE BONE LOSS. NO OTHER COMPLICATIONS WERE NOTED. DEPUY COMPONENTS INCLUDING DEPUY CEMENT WERE USED FOR BOTH KNEES DURING THIS PROCEDURE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 11222670 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2020 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10491271 ↗
• InjuryAug 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED AND WERE REVIEWED: THE DEPUY PATELLAR COMPONENT WAS RETAINED DURING THE LEFT KNEE REVISION ON (B)(6) 2018. FOLLOWING THE REVISION, THE PATIENT WAS NOTED TO BE EXPERIENCING THE FOLLOWING ADVERSE SYMPTOMS ON VARIOUS DATES: PAIN, STIFFNESS, AND SWELLING. THERE IS NO EVIDENCE OF A SECOND REVISION NOR INVASIVE TREATMENT TO ADDRESS THE INDICATED SYMPTOMS INVOLVING THE RETAINED DEPUY PATELLAR COMPONENT AND COMPETITOR PRODUCTS.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Edema; Injury; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10436931 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED TKA. EXPLANTED ALL COMPONENTS WITH CEMENT SPACER IMPLANTATION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10303134 ↗
• InjuryMar 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION OF A REVISION FROM A PREVIOUS INFECTION. NO OTHER INFORMATION AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9830112 ↗
• InjuryFeb 21, 2020Noise, Audible; Noise, Audible

  THE PATIENT WAS REVISED DUE TO PATELLA CREPITUS. OPEN SYNOVECTOMY PERFORMED. POLY EXCHANGE ALSO PERFORMED DUE TO MILD LAXITY. SURGEON COMMENTS ABOUT INCREASED PATELLA CREPITUS WITH SIGMA PS KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9741940 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE, COMPETITOR CEMENT WAS USED.

  Patient problems: Joint Laxity; No Code Available; Pain

  MAUDE report 9510798 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP, CHRONIC INFECTION, POSITIVE CULTURE FOR (B)(6). EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DOI: (B)(6) 2017; DOE: (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9483892 ↗
• InjuryNov 5, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. THE SURGEON DID THE ORIGINAL SURGERY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9279272 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9129538 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFC REVISION KNEE INSITU - SAME INFECTED. ALL IMPLANTS REMOVED, JOINT WASHED OUT AND DEBRIDED EXTENSIVELY. ATTUNE REVISION IMPLANTS INSERTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8447633 ↗
• InjuryNov 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS METAL ALLERGY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8086323 ↗