SIGMA 1960-50-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295075158), received between Aug 3, 2017 and May 9, 2025 — classified as 23 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INCREASED PAIN, REDNESS, AND MILD ERYTHEMA. IV ANTIBIOTICS WAS STARTED FOR TREATMENT OF POSSIBLE CELLULITIS. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Cellulitis; Erythema; Pain

  MAUDE report 21995848 ↗
• InjuryDec 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 18307620 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JANUARY 16, 2014- JUNE 30, 2014, MEDICAL RECORDS REPORTED THAT THE PATIENT UNDERGOES A STEROID INJECTION FOR RIGHT KNEE PAIN AND CREPITATION. DOI: (B)(6) 2012. DOE: UNKNOWN. RIGHT KNEE.

  Patient problems: Pain; Unspecified Musculoskeletal problem

  MAUDE report 17085958 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020: PATIENT COMPLAINS OF RIGHT KNEE PAIN. AN ASPIRATION IS DONE TO RULE OUT INFECTION. DOI: (B)(6) 2012; DOE: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17085643 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE REPLACED (B)(6) 2018. PATIENT SAID IT HURTS, IT WAS DIFFICULT TO BEAR WEIGHT, IT HAD NEVER FELT RIGHT, SWELLS, FEELS UNSTABLE AND DOES NOT HAVE FULL MOTION. PATIENT HAS HISTORY OF METAL SENSITIVITIES. PATIENT TOLD THAT EVEN WEARING ALLOYED EARRINGS WOULD CAUSE FOR BLISTERS. PATIENT HAD ALREADY SEEN PHYSICIAN ASSISTANT AND HAD A WORKUP. INFECTION WORKUP WAS NEGATIVE. SED RATE WAS 1, CRP LESS THAN 5, NEGATIVE CULTURES, NEGATIVE SYNOVASURE, NUCLEATED CELL COUNT 590, PMNS 15. PATIENT HAS HAD A METAL SENSITIVITY TEST WHICH REACTED TO NICKEL. THERE WAS A LOOSENING OF TIBIA IN BONE TO CEMENT INTERFACE. THE CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16940671 ↗
• InjuryFeb 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT WAS REVISED DUE TO PATELLA CLUNK DEBRIDEMENT OF PATELLA SOFT TISSUES TIBIAL POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16377838 ↗
• InjurySep 21, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CONSUMER HAD A REPLACEMENT FOR LEFT AND RIGHT KNEE. CONSUMER HAVE BEEN IN SO MUCH PAIN ON THIS KNEE. THE KNEE THAT THEY PUT IT WAS A BAD KNEE. DOI: (B)(6) 2012, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Pain; Swelling/ Edema; Unspecified Musculoskeletal problem; Unspecified Tissue Injury

  MAUDE report 15461583 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE PAIN. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13826421 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO KNEE INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION. NO SURGICAL DELAY. DOI : (B)(6) 2018; DOR : (B)(6) 2022; AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13659129 ↗
• InjuryAug 9, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2015, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12298044 ↗
• MalfunctionApr 7, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  INTRAOPERATIVELY THE IMPLANT WAS FOUND TO HAVE ADHESIONS OF STERILE PACKAGING MATERIAL ON THE ARTICULATING SURFACE. ANOTHER IMPLANT WAS AVAILABLE AND USED WITHOUT ISSUES. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627377 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED RIGHT KNEE. REMOVAL DATE: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9871640 ↗
• MalfunctionJan 7, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  CUSTOMER SENT IMPLANT TO DOT TO HAVE IT COATED WITH TINI. AT INCOMING INSPECTION DOT IDENTIFIED AN "IRREGULARITY" ON THE IMPLANT AND REFUSED IT TO UNDERGO THE TINI COATING-PROCESS. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558442 ↗
• MalfunctionJan 7, 2020Off-Label Use; Device Contaminated During Manufacture or Shipping; Off-Label Use; Device Contaminated During Manufacture or Shipping

  CUSTOMER SENT IMPLANT TO DOT TO HAVE IT COATED WITH TINI. AT INCOMING INSPECTION DOT IDENTIFIED AN "IRREGULARITY" ON THE IMPLANT AND REFUSED IT TO UNDERGO THE TINI COATING-PROCESS. NO SURGERY DELAY, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9558441 ↗
• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SEPTIC TOTAL KNEE, EXPLANTED DUE TO INFECTION DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT SIDE KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9491866 ↗
• InjuryOct 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE FEMUR AND TIBIA WERE FOUND TO "FELL OUT OF THE PATIENT". REVISED TO A SIGMA TC3 MBT CONSTRUCT. PATELLA WAS NOT REVISED. NO FURTHER PATIENT INFORMATION AVAILABLE. DOI: 2014. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9250237 ↗
• InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2009. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9120658 ↗
• InjuryAug 14, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL NOTIFICATION RECEIVED FOR RIGHT TOTAL KNEE REVISION TO ADDRESS ASEPTIC LOOSENING DATE OF IMPLANTATION: (B)(6) 2012. DATE OF REVISION: 05/05/2019. (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 8895033 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION DUE TO JOINT PROSTHESIS. DEPUY CEMENT WAS USED. NO EXTENDED TIME. PRODUCT NOT AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8436675 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8235541 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL RT TKA WITH ARTHROFIBROSIS.

  Patient problems: Fibrosis; No Code Available; Pain; Scar Tissue

  MAUDE report 8213084 ↗
• InjuryFeb 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED KNEE JOINT.

  Patient problems: Unspecified Infection

  MAUDE report 7298938 ↗
• InjuryJan 22, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN OR EFFUSION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO INDICATED THAT THE WORKUP WAS NEGATIVE FOR INFECTION. DOI: (B)(6) 2015; (B)(6) 2017; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7209740 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND LAXITY OF KNEE JOINT.

  Patient problems: Pain

  MAUDE report 7040886 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND LAXITY OF KNEE JOINT.

  Patient problems: Pain

  MAUDE report 7040876 ↗