SIGMA 96-2365Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295242543), received between Nov 29, 2017 and Dec 15, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED WITH TC3 FEMUR WITH POROUS COATED SLEEVE DUE TO INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23803029 ↗
• InjuryDec 19, 2024Naturally Worn; Naturally Worn

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS T

  Patient problems: Ambulation or Postural Difficulties; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20975478 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TOTAL LEFT KNEE INFECTION. INCISION AND DEBRIDEMENT WITH POLY EXCHANGE WAS PERFORMED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17743982 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15002272 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISE DUE TO INFECTION AND LOOSENING OF THE FEMUR AND TIBIA COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. ALL COMPONENTS ARE BEING REMOVED AND A CEMENT SPACER IS BEING IMPLANTED. PATIENT FIRST REIMPLANTATION USING DEPUY PRODUCTS WAS ON (B)(6) 2020. INCLUDED THE PARTS FROM WHICH NUMBERS COULD BE OBTAINED. THE KNEE HAS AUGMENTS, STEMS AND SLEEVES FROM WHICH NUMBERS COULD NOT BE OBTAINED. PATIENT HAD A POLY EXCHANGE ON (B)(6) 2021. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020 (FEMUR, TIBIA, AUGMENTS, SLEEVE & STEM), (B)(6) 2021 (TIBIAL INSERT), DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12632463 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12583862 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE TENTH REVISION FOR THIS PATIENT; PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2020 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12167991 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. NO DELAY IN SURGERY. DOI: (B)(6) 2012, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 11725194 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REPEAT I&D AND AN EXCHANGE OF THE INSERT WERE DONE. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

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

  MAUDE report 11709080 ↗
• InjuryMar 10, 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. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2017; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11455644 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IRRIGATION AND DEBRIDEMENT WITH EXCHANGE OF POLY INSERT WERE PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9954321 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS SIGNS OF INFECTION. WOUND IRRIGATED AND DEBRIDED, POLY REPLACED WITH NEW ONE. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9602340 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTED KNEE. POLY SWAP WAS DONE. DOI: UNKNOWN; DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9495294 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERGOES A REVISION RIGHT TOTAL KNEE REPLACEMENT TO A HINGED KNEE REPLACEMENT CONSTRUCT DUE TO FAILURE OF RIGHT TOTAL KNEE REPLACEMENT SECONDARY TO INSTABILITY AND POSTEROLATERAL CORNER DEFICIENCY. FEMORAL COMPONENT AND INSERT WERE REVISED AND DEPUY FEMORAL IMPLANT, AUGMENTS, AND TIBIAL INSERT WERE IMPLANTED. DOI: (B)(6) 2017 - DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9402089 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY SWAP WAS DONE. DOI; UNK. DOR: (B)(6) 2019; UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8631497 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A RECURRENT DISLOCATING TC3, SURGEON ELECTED TO REVISE TO SROM HINGE. DOI: (B)(6) 2018; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8595053 ↗
• InjuryNov 26, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8102361 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. REVISED ALL KNEE COMPONENTS AND REMOVED. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7674377 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7071708 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7069722 ↗