SIGMA 1960-50-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295075165), received between Sep 26, 2017 and Jan 5, 2026 — classified as 33 injuries, 2 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AND FEMUR AT IMPLANT CEMENT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2011, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960370 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, ALL IMPLANTS WERE EXPLANTED, NEW IMPLANTS WERE IMPLANTED. THERE WERE NO RECORDS AVAILABLE FOR HOW OLD THE SIGMA KNEE WAS IN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23075921 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21275366 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTED KNEE, REMOVED IMPLANTS. WASHED OUT AND IMPLANTED TEMPORARY IMPLANTS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21143394 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? IF YES, WHAT IS THE DURATION OF THE DELAY? NO.

  Patient problems: Pain

  MAUDE report 19616755 ↗
• InjuryJun 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE DISTAL FLAT & ANTERIOR PART OF FEMORAL COMPONENT. TOTAL KNEE REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19564148 ↗
• InjuryNov 7, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT IMPLANTS PUT KNEE AT 7 DEGREES MORE VALGUS THAN WHAT THE NATIVE KNEE WAS ORIGINALLY. FEMORAL AND TIBIAL COMPONENTS WERE LOOSE. DOI: (B)(6) 2015, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18083270 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR RESECTION FOR STAPHYLOCOCCUS MUTIGEN INFECTION. ALL IMPLANTS REMOVED. AN I&D PLOY EXCHANGE WAS PERFORMED ON (B)(6) 2022. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16270663 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16246213 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION OF RIGHT TOTAL KNEE I & D WASHOUT REMOVAL OF IMPLANTS. ANTIBIOTIC CEMENT SPACERS. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13964454 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INJURED WHEN A LADY FELL ON HIS LEG. POLY EXCHANGED FOR THICKER INSERT WAS DONE. DOI: (B)(6) 2019. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Ecchymosis; Joint Laxity; Muscular Rigidity; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 13265773 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC WAS CREATED FOLLOWING AND ADDITIONAL INFORMATION RECEIVED ON THE MOTHER (B)(4)FOUND IN AEI NOTE (B)(6). ON (B)(6) 2019: R TKA IS PERFORMED. SPECIFIC PART/LOT NOT IDENTIFIED. ON (B)(6) 2019: PATIENT HAS ONGOING STIFFNESS AND PAIN. ON (B)(6) 2019 RIGHT KNEE UNDERGOES MANIPULATION DUE TO LACK OF MOTION. DOI: (B)(6) 2019. DOE: (B)(6) 2019 RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 13154034 ↗
• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. IT WAS INDICATED THERE WAS A POSSIBLE INFECTION. LOOSE TIBIA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 12332827 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT & IMPLANT TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2009 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11495671 ↗
• MalfunctionMar 4, 2021Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE IMPLANT HAD PACKAGING MELTED TO FEMUR IMPLANT. NO SURGICAL DELAY. THE FEMORAL COMPONENT WAS NOT BROKEN. THERE WAS STYROPHOME FROM THE PACKAGING MELTED ONTO THE FEMORAL COMPONENT. ALL PIECES INVOLVED WERE SAVED. EVENT: UNKNOWN, RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11416498 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT SURGERY TIME WAS NOT EXTENDED.

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

  MAUDE report 11280346 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2016 DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11251816 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TKR- PATIENT HAD A FALL ON KNEE 18 MONTHS POST PRIMARY TKR. SIX WEEKS AFTER FALL PATIENT STARTED EXPERIENCING PAIN AND INSTABILITY.

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 11065913 ↗
• InjuryDec 18, 2020Loss of or Failure to Bond; Patient Device Interaction Problem; Loss of or Failure to Bond; Patient Device Interaction Problem

  MEDICAL RECORDS/BILLING RECORDS WERE REVIEWED: ON (B)(6) 2018, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSENING TIBIAL TRAY AT THE IMPLANT/CEMENT INTERFACE, PAIN, EFFUSION, CLUNKING AND INABILITY TO PERFORM HIS NORMAL FUNCTION. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSENED ¿WAS CLEANED AND RE-CEMENTED¿, THE PATELLA WAS NOTED TO BE WELL FIXED AND WAS RETAINED. ON (B)(6) 2018, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE, PAIN, SWELLING, AND DIFFICULTY WITH WALKING. THE PATELLA AND FEMORAL COMPONENTS WERE NOTED TO BE WELL-FIXED AND WERE RETAINED. THE INSERT WAS REMOVED WITHOUT ALLEGATION OF DEFICIENCY. (STICKER PAGE 46 OF 97) DEPUY TIBIAL TRAY AND INSERT WERE USED AS WELL AS COMPETITOR CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2019, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSE RIGHT TOTAL KNEE. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A PREVIOUS REVISION FOR ASEPTIC LOOSENING OF HIS TIBIAL PLATEAU. THE PATIENT NOW HAS LOOSENING OF THE FEMORAL COMPONENT AS WELL AS THE PATELLAR COMPONENT, SEVERE POPPING AND SNAPPING AN

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Local Reaction; Pain

  MAUDE report 11037657 ↗
• InjuryDec 18, 2020Loss of or Failure to Bond; Off-Label Use; Patient Device Interaction Problem; Loss of or Failure to Bond; Off-Label Use; Patient Device Interaction Problem

  MEDICAL AND BILLING RECORDS RECEIVED AND WERE REVIEWED: OFFICE NOTES (B)(6) 2021- (B)(6) 2019 INDICATE THE PATIENT IS EXPERIENCING SWELLING, POPPING, INSTABILITY AND PAIN OF THE LEFT KNEE. HE IS ALSO EXPERIENCING SWELLING, PAIN, NUMBNESS AND INSTABILITY IN THE RIGHT KNEE AND FEELINGS OF CRUNCHING AND CRACKING. CURRENT TREATMENT INCLUDES ORAL PAIN MEDICATION, PHYSICAL THERAPY, KNEE BRACES AND NERVE BLOCKS. NO EVIDENCE OF ADDITIONAL REVISION OF PRODUCTS.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 11037461 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

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

  MAUDE report 10895670 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION SO DOCTOR REMOVED IMPLANTS AND PUT IN TEMPORARY SPACER FOR 2 STAGE REVISION KNEE. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10819112 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. FEMUR INSERTED (B)(6) 2019, INSERT EXCHANGED (B)(6) 2019. FEMUR AND INSERT REMOVED AND CONVERTED TO HINGED PROSTHESES AS MCL WAS FOUND TO BE INCOMPETENT. CEMENT IS IN HOSPITAL INVENTORY SO NO RECORD AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2019 - FEMORAL. DOI: (B)(6) 2019 - INSERT. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Contracture; Joint Laxity; No Code Available; Pain; Swelling/ Edema; Synovitis

  MAUDE report 10595933 ↗
• InjurySep 16, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OPERATIVE NOTES 10/26/2015 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN, STIFFNESS AND HARDWARE FAILURE. UPON ENTERING THE JOINT, SIGNIFICANT SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE BOLT WAS FOUND BROKEN AND HAD FALLEN OUT OF THE INTRACONDULAR NOTCH. THE BROKEN PORTION OF THE BOLT WAS STILL IN THE SLEEVE. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSE. FEMORAL COMPONENTS AND INSERT WERE REVISED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PRODUCTS IMPLANTED AT THIS REVISION ARE LOCATED ON PAGE 13-15. DOI: (B)(6) 2013. DOR: (B)(6) 2015. RIGHT KNEE.

  Patient problems: Adhesion(s); Muscular Rigidity; No Code Available; Pain

  MAUDE report 10542095 ↗
• InjuryFeb 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HARMED BY ONE OF YOUR MEDICAL DEVICES. SIGMA PFC WITH CMW3 FAILURE. DOI: (B)(6) 2010; DOR: (B)(6) 2018; RIGHT LEG.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9693759 ↗