SIGMA 1960-50-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295075127), received between Jan 9, 2018 and Dec 26, 2024 — classified as 31 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Difficult to Insert; Difficult to Insert

  THE FEMORAL COMPONENT DID NOT FIT CORRECTLY INTO THE CUTS MADE. EVEN AFTER REVIEWING THE CUTS, SURGERY WAS DELAYED 5 MINUTES. A NEW COMPONENT WAS OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019433 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. THERE WAS A LOOSENING REPORTED AT THE TIBIA AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18425963 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "I AM CALLING FROM CUSTOMER SERVICE CALLING IN A PRODUCT COMPLAINT FOR JOINT RECONSTRUCTION AND THE CASE NUMBER (B)(4). CALLER DID SAY THEY ARE HAVING AN ALLERGIC REACTION TO THE ITEMS FROM SURGERY FOR KNEE REPLACEMENT ONE OF ITEM NUMBER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18055710 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF UNSTABLE KNEE AND WAS REVISED TO AN S-ROM HINGE KNEE DUE TO MEDICAL COLLATERAL LAXITY. NO EXPLANATION FOR LAXITY OF THE MCL LIGAMENT APPARENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17142667 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17058458 ↗
• InjuryDec 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2013. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15983591 ↗
• InjuryOct 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(4) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 15690962 ↗
• MalfunctionSep 8, 2022No Apparent Adverse Event; Inaccurate Information; No Apparent Adverse Event; Inaccurate Information

  EVENT DESCRIPTION: AN AR-MEDICA CLIENT CONTACTED US COMPLAINING THAT THE COUNTRY OF ORIGIN DOES NOT MATCH BETWEEN THE SHIPPING INVOICE AND THE BOX LABEL. AT THE MOMENT, CUSTOMS HAS IDENTIFIED 7 CODES IN THE DEPUY BUSINESS WITH SUCH A DISCREPANCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384567 ↗
• MalfunctionSep 8, 2022No Apparent Adverse Event; Inaccurate Information; No Apparent Adverse Event; Inaccurate Information

  EVENT DESCRIPTION: AN AR-MEDICA CLIENT CONTACTED US COMPLAINING THAT THE COUNTRY OF ORIGIN DOES NOT MATCH BETWEEN THE SHIPPING INVOICE AND THE BOX LABEL. AT THE MOMENT, CUSTOMS HAS IDENTIFIED 7 CODES IN THE DEPUY BUSINESS WITH SUCH A DISCREPANCY. PHOTOS OF CODES AND SHIPPING INVOICE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15384407 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PT HAD DONE WELL WITH PRIMARY TOTAL KNEE UNTIL EXPERIENCING A FALL AND THEN BECAME PAINFUL. SURGEON NOTED MILD LAXITY IN EXTENSION BUT MORE SIGNIFICANT INSTABILITY IN FLEXION. A POLY EXCHANGE WAS ATTEMPTED LOS OF EXTENSION WAS NOTED AND PATELLA WAS RIDING TOO LOW AS THE KNEE WAS FLEXED WHEN POLY THICKNESS WAS INCREASED TO STABILIZE FLEXION. ALL COMPONENTS WERE REMOVED AND A REVISION TOTAL KNEE WAS PERFORMED. TIBIA COMPONENT WAS FOUND TO BE LOOSE WHEN SURGEON BEGAN TO REMOVE. ULTIMATELY, A HINGED PROSTHESIS HAD TO BE UTILIZED TO STABILIZE THE FLEXION GAP AND ADDRESS THE JOINT LINE FOR PATELLAR POSITION. THERE WAS NO PATIENT HARM. INSTABILITY WAS NOT DUE TO WEAR, MALALIGNMENT, NOR UNDER SIZING OR OVER RESECTION. NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 15100040 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PERIPROSTHETIC FRACTURE DISTAL FEMUR ABOVE FEMORAL COMPONENT. DISTAL FEMORAL REPLACEMENT WAS REQUIRED. TIBIAL COMPONENT WAS WELL FIXED AND ALIGNED BUT WAS REVISED TO ACCOMMODATE DFR FEMORAL COMPONENT. PATELLA COMPONENT WAS NOT REVISED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2017, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 13224954 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR ABOVE THE FEMORAL COMPONENT. DISTAL FEMORAL REPLACEMENT REQUIRED. THE TIBIAL COMPONENT WAS WELL FIXED AND ALIGNED BUT WAS REVISED TO ACCOMMODATE THE DFR FEMORAL COMPONENT. PATELLA COMPONENT WAS NOT REVISED. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2017; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 13167565 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: THE PATIENT WAS REVISED TO ADDRESS INFECTION TWO YEARS AFTER POST OP. DOI: UNK; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12422326 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. FEMUR WAS LOOSE AT THE CEMENT TO BONE INTERPHASE AND THE TIBIA WAS LOOSE AT THE CEMENT TO IMPLANT INTERPHASE. UNKNOWN BONE CEMENT WAS USED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2018. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11921095 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL OF TOTAL JOINT AND PLACEMENT OF ANTIBIOTIC SPACER DUE TO INFECTION. LOOSENING REPORTED ON THE FEMORAL COMPONENT AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER NOT PROVIDED. DOI: (B)(6) 2015, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11614355 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND POLY WEAR-INDUCED SYNOVITIS. THE PATIENT'S PRIMARY SIGMA FB RP KNEE COMPONENTS WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. DOI: (B)(6) 2009, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Pain; Synovitis

  MAUDE report 11093189 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FLEXION INSTABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10195484 ↗
• InjuryApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PRIMARY SURGERY WAS PERFORMED VIA TKA WITH THE SIGMA PS FEMORAL COMPONENT (P/N: 196050250) AND THE TIBIAL ROD (P/N: 866416) IN QUESTION. IN ROUTINE CHECKUP IN (B)(6), THE SURGEON CONFIRMED THAT THERE WAS NO PROBLEM, BUT ON (B)(6) 2020, THE PATIENT REPORTED KNEE SWELLING. THE SURGEON CONFIRMED THAT THE FEMORAL SUPRACONDYLAR FRACTURE OCCURRED. ON (B)(6) THE PATIENT UNDERWENT THE REVISION SURGERY BY REPLACING THE COMPONENT AND ROD WITH THE FEMORAL COMPONENT (P/N: 960087) AND STEM (P/N: 961731). NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 9943551 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE REVISION; ORIGINAL SURGERY DONE (B)(6) 2015. PATIENT COMPLAINED OF STIFFNESS AND ANTERIOR PAIN. REMOVED POLY, TRAY AND FEMUR.

  Patient problems: Muscular Rigidity; No Code Available; Pain

  MAUDE report 9834956 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF RIGHT TKA DUE TO PATIENT PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 9758110 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EVENT DESCRIBE AS NO INFORMATION PROVIDED. AFFECTED SIDE: RIGHT SIDE.

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

  MAUDE report 9596137 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO THE PREVIOUSLY REPORTED ADVERSE SYMPTOMS, THE PATIENT WAS ALSO EXPERIENCING THE FOLLOWING PRIOR TO REVISION ON (B)(6) 2018: FALL, WARMTH, DIFFICULTY SLEEPING, REDNESS, AND CREPITUS. AFTER THE REVISION OPERATION ON (B)(6) 2018 WHERE THE DEPUY PATELLAR COMPONENT WAS RETAINED WITH COMPETITOR PRODUCTS AND UNKNOWN CEMENT, THE PATIENT WENT ON TO EXPERIENCE THE FOLLOWING CONTINUED ADVERSE SYMPTOMS: FALL, PAIN, DECREASED RANGE OF MOTION, STIFFNESS, EDEMA, WARMTH, STIFFNESS, REDNESS, AND CONTRACTURE. THERE IS NO EVIDENCE OF A SECOND REVISION NOR INVASIVE INTERVENTION INVOLVING THE RIGHT KNEE. THE RETAINED DEPUY PATELLAR COMPONENT WAS PREVIOUSLY REPORTED FOR THE CONTINUED ADVERSE SYMPTOMS.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Edema; Erythema; Fall; Joint Contracture; Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available; Pain; Rash; Weakness

  MAUDE report 9557566 ↗
• InjuryJan 2, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS FALL AND LOOSENING OF THE IMPLANT AT CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2016. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9540905 ↗
• InjuryDec 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2012; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 9490934 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. PREVIOUS SURGICAL DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9413054 ↗