SIGMA 1960-40-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295075028), received between Aug 18, 2017 and Oct 29, 2024 — classified as 15 injuries, 3 malfunctions.

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH PFC SIGMA RIGHT IN 2009. POST-IMPLANT, THE PATIENT EXPERIENCED INSTABILITY AND VALGUS. IMPLANT WAS REMOVED.

  Patient problems: Joint Laxity

  MAUDE report 20555759 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20401525 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY WITH THE COMPETITOR'S IMPLANTS. AFTER THE SURGERY, THE PATIENT UNDERWENT THE REVISION SURGERY WITH THE FEMORAL COMPONENT IN QUESTION AND THE INSERT IN QUESTION ON (B)(6) 2018, FOR UNKNOWN REASON. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE REVISION SURGERY, THE IMPLANTS HAD AN INSTABILITY ON AN UNKNOWN DATE. THEN, THE PATIENT UNDERWENT THE 3RD SURGERY WITH THE TC3 AND TC3 INSERT ON (B)(6) 2022. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2018. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 15804157 ↗
• MalfunctionSep 9, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PACKAGING CANNOT BE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392578 ↗
• MalfunctionMay 31, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient Device Interaction Problem

  SUBJECT ID: (B)(6), STUDY NO; DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SIGNIFICANT CREPITUS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020; DATE OF EVENT (ONSET): (B)(6) 2022 (LEFT KNEE). TREATMENT: REVISION SURGERY.

  Patient problems: Adhesion(s); Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; No Clinical Signs, Symptoms or Conditions; Pain; Swelling/ Edema

  MAUDE report 14556013 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CHANGE OF A TOTAL PFC PS RP PROSTHESIS WHICH WAS PAINFUL. NO SIGNS OF LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 14453800 ↗
• InjuryApr 13, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  STUDY: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PATELLAR GRINDING, CLUNK : PATELLA CLUNK SYNDROME. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF REVISION #1: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11657156 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GROSS INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. DATE OF ORIGINAL SURGERY IS UNKNOWN. WITH A SURGICAL DELAY OF UNKNOWN MINUTES. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11589986 ↗
• InjurySep 17, 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) 2015 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10547351 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND SUBLUXATION. THE SURGEON DECIDED TO REMOVE HER PRIMARY KNEE AND REPLACE WITH A MORE CONSTRAINED KNEE PROSTHESIS. THE SURGEON REMOVED THE ORIGINAL COMPONENTS AND REPLACED WITH ATTUNE REVISION IMPLANTS WITH SLEEVE AND STEMS. NO ONE MENTIONED A PROBLEM WITH THE ORIGINAL IMPLANTS BUT DID NOTICE THE POLY LOOKED WORN ON THE POSTERIOR SIDE BOTH MEDIAL AND LATERAL SIDES. THEY WERE ABLE TO RECOVER COMPONENT SIZES BUT THE HOSPITAL BUYS THEIR OWN CEMENT SO THEY DO NOT KNOW THE MANUFACTURER. DOI: (B)(6) 2013, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10530964 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10133791 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED HER PRIMARY TKR ON THE (B)(6) 2012. PATIENT REVISED FOR INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 9672213 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS WERE REVISED TODAY, REASON FOR REVISION WAS DUE TO FAILURE OF THE PATIENTS ANATOMY.

  Patient problems: No Code Available; Pain

  MAUDE report 9616387 ↗
• InjuryMar 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION FOR PATELLA TRACKING NOT OPTIMAL AND ALSO KNEE GENERALLY VERY TIGHT. FEMORAL COMPONENT WAS LEFT INSITU.

  Patient problems: Joint Disorder; No Code Available

  MAUDE report 8382684 ↗
• InjuryOct 26, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Code Available

  MAUDE report 8009763 ↗
• MalfunctionMay 2, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE CEMENT WAS OVERFLOWED OUT OF THE HOLE OF THE REPORTED IMPLANT WHEN THE SURGEON INSERTED THE IMPLANT DURING TKA SURGERY ON (B)(6) 2018. THE SURGEON FOUND THAT THERE WAS NO POLYETHYLENE PART TO COVER THE HOLE OF THE IMPLANT. THE SURGERY WAS COMPLETED BY SCRAPPING OFF OF THE OVERFLOWING CEMENT, BUT THE CEMENT WAS REMAINED AROUND THE HOLE. AFTER SURGERY, THE SURGEON SEARCHED FOR THE CONTAINER IN WHICH THE IMPLANT WAS IN, BUT COULD NOT FIND THE POLYETHYLENE PARTS. THERE WAS NO SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479096 ↗
• InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. LOOSENING OCCURRED AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 6837661 ↗
• InjuryAug 18, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT. LOOSENING INTERFACE OCCUR AT THE BONE TO CEMENT AND CEMENT TO IMPLANT. CEMENT MANUFACTURER IS COMPETITOR. IT WAS ALSO REPORTED THAT HALF OF THE FEMUR HAD NO CEMENT APPLIED TO BONE OR IMPLANT.

  Patient problems: No Code Available; Pain

  MAUDE report 6804706 ↗