SIGMA 1960-40-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10603295075035), received between Jul 24, 2017 and May 4, 2026 — classified as 27 injuries, 4 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 31 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT INFECTED KNEE WITH LOOSENING. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25070745 ↗
• MalfunctionMar 20, 2024Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED: A. WHAT IS THE EVENT DATE 8TH MARCH 2024. B. IT WAS MENTIONED IN THE EVENT DESCRIPTION THAT " THERE IS NO DAMAGE IN THE IMPLANT PRESENT INSIDE THE BOX, SO THE IMPLANTS WERE USED. " BUT THE PRODUCT RETURN STATUS OF THE IMPACTED PRODUCT IS AVAILABLE FOR RETURN. PLEASE CONFIRM, IS THE PRODUCT AVAILABLE FOR RETURN? YES OR NO? THE OUTER MELTED BOX WAS RETURNED TO PAREKH INTEGRATED SERVICES PVT LTD, BHIWANDI C. CAN YOU PLEASE CONFIRM THE QUANTITY OF IMPLANTS WERE USED WITH THE SAME PACKAGING ISSUE? 1 QTY. D. WAS THERE ANY PATIENT CONSEQUENCES? NO. E. WHAT IS THE ACCOUNT/HOSPITAL NAME? (B)(6) HOSPITAL. NOTE: KINDLY PROVIDE THE SOURCE OF THE INFORMATION (I.E. INFORMATION RECEIVED FROM DR, NURSE ETC.) ¿ I WAS THERE AT OT AT THE TIME OF INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 18942193 ↗
• InjuryDec 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED. THE INDICATIONS, FOR SURGERY INCLUDED PAIN AND SWELLING.

  Patient problems: Adhesion(s); Insufficient Information; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 18363122 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WENT TO THE SURGEON DUE TO PAIN AND INSTABILITY OF THE LEFT KNEE. UPON PHYSICAL EXAM SURGEON NOTED INSTABILITY IN THE KNEE JOINT. X-RAY OF THE LEFT KNEE SHOWED SUBSIDENCE OF THE MEDIAL SIDE OF THE TIBIAL COMPONENT. DURING THE SURGERY IT WAS NOTED THAT THE FEMUR WAS WELL FIXED. THE TIBIAL COMPONENT WAS LOOSE AT THE CEMENT TO IMPLANT INTERFACE. CEMENT WAS FIXED TO THE BONE BUT NO CEMENT CAME OUT WITH THE TIBIAL COMPONENT. DEPUY CEMENT WAS USED. ATTUNE REVISION COMPONENTS WERE USED FOR THE SURGERY. ONCE COMPONENTS WERE IMPLANTED, IT WAS NOTED THAT THE KNEE WAS STABLE AND HAD GREAT RANGE OF MOTION. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17743905 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT OF MINE HAD A LEFT KNEE REPLACEMENT ( OP NOTE ENCLOSED ). A 2.5 SIZED CRUCIATE SACRIFICING TKR WAS PERFORMED. HER POST OP RANGE ON THE TABLE WAS 3 - 120 DEGREES. ( ON THE RIGHT SIDE A SIZE 3 WAS INSERTED). A FEW MONTHS LATER THE RANGE OF MOVEMENT IN THE LEFT KNEE REDUCED AND IN OCTOBER 2021 WAS 30 - 75 DEGREES. THE KNEE WAS REVISED AT ANOTHER HOSPITAL. PATIENT HAS COMPLAINED TO ME: THAT I HAVE USED TOO BIG A PROSTHESIS. THE IMPLANT IS TOO DISTAL.

  Patient problems: Loss of Range of Motion

  MAUDE report 16992141 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TOTAL KNEE, EXPLANTED AND ANTIBIOTICS SPACER IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16572597 ↗
• 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 15384547 ↗
• 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 15384328 ↗
• 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 15384307 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN AND SWELLING SECONDARY TO A FALL ON (B)(6) 2022.

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

  MAUDE report 15289481 ↗
• InjuryJun 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6), 2020, DOR: (B)(6), 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14733875 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. SURGEON THOUGHT THERE WAS A FLEXION EXTENSION MISMATCH. DOI: UNKNOWN; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12616775 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL LEFT KNEE. DOI: (B)(6) 2021 , DOR: (B)(6) 2021, (LEFT KNEE).

  Patient problems: Pain

  MAUDE report 12531926 ↗
• InjuryJun 29, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA OF LEFT SIDE OF KNEE. AFTER SURGERY, LOOSENING OF THE FEMUR WAS FOUND. THE SURGEON SUSPECTED INFECTION AND EXAMINED, BUT THERE WAS NO SIGN OF INFECTION. THE SURGEON JUDGED IT TO BE ASEPTIC LOOSENING. WITH A TIBIAL BONE DEFECT. ALLOGENEIC BONE GRAFTING WAS PERFORMED ON THE FEMUR. AN EXTENSION STEM WAS ATTACHED TO THE IMPLANT AND REPLACED TC3, WHICH IS MORE RESTRICTIVE. DOI: (B)(6) 2020. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 12087288 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD SKIN ISSUE AND HAD HER PATELLA IMPLANT PROTRUDING EXTERNALLY. ALL IMPLANTS FOUND TO BE LOOSE AND WERE REPLACED. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REVISION SURGERY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (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: Joint Laxity; Wound Dehiscence

  MAUDE report 11843456 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDED PATIENT CODES WOUND SECRETION (WOUND DRAINING WAS REPORTED DURING THE CLINIC VISIT ON (B)(6) 2020, AND INFECTION (REVISION OF THE INSERT WAS DONE ON (B)(6) 2020, DUE TO INFECTION.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10691153 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT FLEXION. DOI: (B)(6) 2012, DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10542043 ↗
• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANTS WERE REMOVED DUE TO KNEE STIFFNESS.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 10465826 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2018. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10189963 ↗
• InjuryNov 14, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF LEFT SIGMA POSTERIOR STABILIZED ROTATING PLATFORM KNEE DUE TO ASEPTIC LOOSENING OF THE FEMUR AND TIBIA.

  Patient problems: No Code Available

  MAUDE report 9322038 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO IMPLANT RECORD FOR PATELLA. NO MARKINGS VISIBLE FOR SZ/LOT. DOI: (B)(6) 2004. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9287667 ↗
• InjuryNov 4, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 09 OCTOBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2014, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS AND VARUS DEFORMITY. THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING. THE SURGEON REPORTED THE PATELLA WAS UNSTABLE AND REMOVED EASILY, AND REVISED. HE INDICATED THE FEMORAL COMPONENT WAS MODERATELY FIXED, ALTHOUGH LOOSE LATERALLY, AND WAS REVISED. THE SURGEON NOTED THE TIBIAL COMPONENT AND POLY HAD SUNK INTO THE TIBIA AND WERE GROSSLY UNSTABLE, AND REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND DEPUY CEMENT X 3. THERE WERE NO COMPLICATIONS REPORTED TO THE PROCEDURE. DOI: (B)(6) 2014. DOR: (B)(6) 2017 (LT KNEE).

  Patient problems: No Code Available

  MAUDE report 9272290 ↗
• InjuryAug 26, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT AN UNKNOWN INTERFACE. UNKNOWN CEMENT USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2012. DOR: (B)(6) 2017; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8929926 ↗
• InjuryJul 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ASEPTIC LOOSING OF TIBIA AND FEMUR. CEMENT / IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8831350 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A LEFT SIGMA TKA ON (B)(6) 2016. SHE LATER WAS REVISED ON (B)(6) 2017 TO A COMPETITOR¿S SYSTEM FOR PAIN AND CONSIDERABLE LIGAMENTOUS INSTABILITY. ¿THE TIBIA AT THE KNEE WAS SO LOOSE I COULD SUBLUX THE TIBIA FORWARD AND PULL THE PLASTIC OUT.¿

  Patient problems: No Code Available; Pain

  MAUDE report 8536843 ↗