SIGMA 1960-50-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295075141), received between Jun 26, 2017 and Apr 20, 2026 — classified as 44 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (12 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO PAIN IN RIGHT KNEE. UPON EXAMINATION IT WAS NOTED THAT THE RIGHT KNEE WAS UNSTABLE AND X-RAY SHOWED THAT THE FEMORAL COMPONENT HAD SUBSIDED ON THE MEDIAL SIDE. DURING REVISION SURGERY IT WAS NOTED THAT THE FEMORAL COMPONENT WAS LOOSE AND HAD DELAMINATED FROM THE CEMENT AT THE CEMENT-TO-IMPLANT INTERFACE, WHILE THE TIBIAL COMPONENT WAS WELL FIXED. A FULL REVISION WAS PERFORMED, RESULTING IN A STABLE KNEE WITH GOOD RANGE OF MOTION. DOI: (B)(6) 2018. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24927371 ↗
• InjuryApr 29, 2024Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A. PLEASE CLARIFY IF THE TIBIAL TRAY AND PATELLA WAS NOT REVISED. NO BECAUSE TIBIA AND PATELLA ARE OK. B. PLEASE CLARIFY IF THERE WAS AN ISSUE WITH THE PATIENT'S BONE QUALITY AS NOTED WITHIN A-11018777. WAS IT DEVICE/PROCEDURE RELATED FOR DUE TO THE PATIENT? NO.

  Patient problems: Joint Laxity

  MAUDE report 19201871 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AND UPSIZED FEMORAL IMPLANT DUE TO FLEXION INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6), 2023. DOR- (B)(6), 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18305803 ↗
• InjuryOct 24, 2023Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS LOOSENING.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 17994615 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION OF RIGHT KNEE. ALL IMPLANTS WERE REMOVED. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16862099 ↗
• InjuryFeb 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 POLYETHYLENE WEAR, NO MALPOSITION, COMPONENTS WERE NOT UNDERSIZED ON THE PRIMARY SURGERY, NO LOOSENING AND NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 16452437 ↗
• InjuryFeb 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AND FEMUR AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. TIBIA COLLAPSED INTO VARUS. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16304405 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INFECTION ON RIGHT KNEE. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15927773 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED FOR INFECTION. SPACER PLACED. NOTHING FURTHER TO REPORT, NO SURGICAL DELAY, NO LOOSENING. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15527953 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SPOKE WITH PATIENT ON PHONE TODAY (B)(6) 2022. PATIENT STATES HIS PRIMARY WAS DONE IN MUNSTER, IN ON (B)(6)2019 WITH DEPUY IMPLANTS. HE HAS NOW HAD A REVISION ON (B)(6) 2022. HE STATES THE TRAY WAS TILTED AND PRIOR TO THE REVISION, HE HAD PAIN AND DIFFICULTY WALKING. PART/LOT PROVIDED OF THE FEMORAL AND INSERT ARE BELOW. HE DID NOT HAVE ANY INFORMATION REGARDING THE TRAY. HE THEN REQUESTED COMPENSATION AND HIS INFORMATION HAS BEEN FORWARDED TO LEGAL (SEE (B)(4) LEGAL NOTIFICATION). HE WAS ALSO PROVIDED THE CONTACT INFORMATION OF THE LEGAL PARALEGAL. HE HAS NO FURTHER NEEDS AT THIS TIME. DOI: (B)(6) 2019. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15311819 ↗
• InjuryAug 4, 2022Use of Device Problem; Use of Device Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND MALALIGNMENT OF THE RIGHT KNEE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15164957 ↗
• InjuryAug 4, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. PRIMARY PROCEDURE WAS PERFORMED APPROXIMATELY 18 YEARS AGO. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: APPROX. 18 YEARS AGO; DOR: (B)(6) 2022; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15163465 ↗
• InjuryFeb 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT UNDERWENT REVISION DUE TO PAINFUL KNEE. FEMORAL COMPONENT WAS FOUND TO BE LOOSE AT CEMENT TO IMPLANT INTERFACE DURING REVISION. UNKNOWN CEMENT USED. ALL HARDWARE WERE REMOVED AND REVISED TO AN ATTUNE REVISION FEMORAL COMPONENT WITH 16X60 STEM AND REVISION TIBIAL COMPONENT WITH S3 TIBIAL SLEEVE AND 16X60 STEM AND 12 MM POLY. DOI: 2008; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13544220 ↗
• InjuryFeb 16, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. FEMORAL COMPONENT WAS FOUND TO BE LOOSE DURING REVISION. ALL HARDWARE WERE REMOVED AND REVISED TO AN ATTUNE REVISION FEMORAL COMPONENT AND REVISION TIBIAL COMPONENT WITH TIBIAL SLEEVE AND POLY. DOI: 2008, DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13541844 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO LABS BACK TO DETERMINE TYPE OF INFECTION. ALL IMPLANTS WERE REMOVED. DOI : (B)(6) 2018, DOR : (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13205617 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12583496 ↗
• InjurySep 7, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POLY WEAR WAS ON THE INSERT. THE PATELLA WAS FRACTURED SO WEAR WAS DIFFICULT TO DETERMINE.

  Patient problems: Insufficient Information

  MAUDE report 12435178 ↗
• InjuryApr 15, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. NO DELAY IN SURGERY. DOI: (B)(6) 2014. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11671857 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 11289932 ↗
• 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 RIGHT TOTAL KNEE TO ADDRESS INFECTION DATE OF IMPLANTATION: (B)(6) 2017, DATE OF REVISION: (B)(6) 2021, (RIGHT KNEE). TREATMENT: EXPLANTATION OF ALL IMPLANTS.

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

  MAUDE report 11251468 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  KNEE LITIGATION RECORD RECEIVED. LITIGATION RECORD ALLEGES PAIN, DISCOMFORT, INSTABILITY, DIFFICULTY AMBULATING AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT AN UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2015, DOR: (B)(6) 2018, RIGHT KNEE. ADDITIONAL INFORMATION: 12/17/2020: SURGEON USES DEPUY 2 ((B)(4)) OR DEPUY 2 WITH GENT ((B)(4)) BASED ON PATIENT. HE WOULD HAVE LIKELY USED 2 BATCHES WHICH IS HIS NORM.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Joint Laxity; Pain

  MAUDE report 11083532 ↗
• InjuryOct 21, 2020Naturally Worn; Naturally Worn

  MEDICAL RECORDS AND X-RAY FILMS RECEIVED ON (B)(6) 2019. DOI: (B)(6) 2016, DOR: UNKNOWN, RIGHT KNEE.

  Patient problems: Adhesion(s); Edema; Hypersensitivity/Allergic reaction; Inflammation; Muscular Rigidity; No Code Available; Pain

  MAUDE report 10715467 ↗
• InjuryJun 17, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS ASEPTIC LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10160959 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION OF THE KNEE. ALL IMPLANTS EXPLANTED. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9905472 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED RIGHT KNEE. REMOVED (B)(6) 2019. PATIENT STATUS/ OUTCOME / CONSEQUENCES: UNKNOWN, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-(B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-(B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, IP-(B)(4) DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 9570623 ↗