SIGMA 96-2352Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295242352), received between Oct 4, 2017 and Jan 26, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FORMED HETEROTOPIC OSSIFICATION. DOI: (B)(6) 2020, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification

  MAUDE report 24178007 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOSS OF MOBILITY DUE TO SUSPECTED HETEROTOPIC OSSIFICATION. THE PATIENT HAD A DEPUY TC3 RP REVISION KNEE. THE SZ 4 TC3 RIGHT FEMUR, 5 DEGREE BOLT, +2/-2 FEMORAL ADAPTOR, TC3 SZ 4 X 4 DISTAL AUGMENTS X2, TC3 SZ 4 X 4 POSTERIOR AUGMENT, 115 X 16 STEM AND TC3 RP SZ 4 X 12.5 INSERT WERE EXPLANTED. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 20646627 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT I&D WITH POLY SWAP FOR SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2017. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19939677 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TIBIA. DOI: (B)(6) 2020 DOR: (B)(6) 2023 AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 18138728 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17549938 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION OF A KNEE AND A SUBSEQUENT POLY EXCHANGE WAS PERFORMED. DOI: ON (B)(6) 2018, DOR: ON (B)(6) 2021, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17218015 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 16775191 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. POLY WAS EXCHANGED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12846753 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. BROUGHT TO OPERATING ROOM AND THICKER POLY WAS PLACED AND INSTABILITY WAS RESOLVED. SURGEON BELIEF WAS PATIENT HAS STRETCHED OUT OVER TIME AS SHE HAD BEEN WELL FUNCTIONING FOR A GOOD PERIOD OF TIME. NO WEAR WAS NOTED NOR IMPLANT MISALIGNMENT THAT LED TO INSTABILITY. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2018. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11691290 ↗
• InjuryJan 5, 2021Adverse 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 11117131 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 10748779 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10621940 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE PRESENTED AS PAINFUL, SWOLLEN AND DRAINING FLUID. DURING SURGERY, IT WAS NOTED THERE WAS MICRO MOTION OF THE FEMUR DUE TO BONE LOSS OF THE DISTAL FEMUR. THE FEMORAL SLEEVE WAS WELL FIXED. THE TIBIAL COMPONENT WAS ALSO WELL FIXED. ALL IMPLANTS WERE REMOVED. AN ANTIBIOTIC CEMENT SPACER WAS IMPLANTED. DOI: (B)(6) 2017. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 10580796 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT KNEE I & D WITH INSERT EXCHANGE TO TREAT POSTOPERATIVE INFECTION. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXTRACTED ABUNDANT PERIARTICULAR PUS. THE SURGEON CONFIRMED GROSS INFECTION OF THE JOINT SPACE. THE INSERT WAS WITHOUT DEFECT AND EXCHANGED FOR A LIKE TC3 INSERT. PERIARTICULAR INFECTED TISSUE WAS EXCISED, AND GENTLE DEBRIDEMENT PERFORMED WITH METHYLENE BLUE AND THOROUGH IRRIGATION WITH SALINE. TISSUE AND PUS WERE SENT FOR CULTURE. THE SURGEON BELIEVES THIS INFECTION IS A RESULT OF THE BONE DECOMPRESSION PERFORMED ON (B)(6) 2019 AS THERE WAS NO INFECTION PRESENT IN THAT CASE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. POSTOPERATIVE PATHOLOGY CONFIRMED A DEEP INFECTION OF (B)(6). PATIENT WAS PRESCRIBED IV ANTIBIOTICS FOR 6 WEEKS AND LONG-TERM ORAL ANTIBIOTIC THERAPY. PATIENT RECEIVED A RIGHT SURGICAL REPAIR OF A POSTOPERATIVE SUPERFICIAL WOUND DEHISCENCE. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EXCISED ALL FRIABLE TISSUE AND A MUCOUS LIKE MEMBRANE FROM THE CAPSULE. THE DEEP CAPSULAR REPAIR HAD PARTIALLY DEHISCED AND WAS REPAIRED WITH COMPETITOR SUTURE. THE SURGEON PERFORMED A THOROUGH ANTIBIOTIC WASH-OUT. THERE WERE NO PRO

  Patient problems: Edema; Muscular Rigidity; No Code Available; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 10254402 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED STAGE 1 OF A TWO-STAGE REVISION OF THE RIGHT KNEE TO TREAT PAIN, SWELLING, WALKING DIFFICULTY, AND PRURITIS SECONDARY CHRONIC INFECTION PROGRESSING TO SEVERE SEPSIS. UPON ENTERING THE JOINT, THE SURGEON ENCOUNTERS AND REMOVED GROSS PURULENCE FROM THE JOINT. SIGNIFICANT SYNOVITIS AND INFECTED TISSUE WERE DEBRIDED. ALL COMPONENTS WERE EXPLANTED AND REPLACED WITH DEPUY PRODUCTS AND COMPETITOR CEMENT X 5, AND STIMULAN ANTIBIOTIC BEADS. THE PATIENT WAS IMPLANTED WITH DEPUY PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT WAS PLACED ON 6-WEEK IV ANTIBIOTICS. STAGE TWO REVISION IS SCHEDULED FOR 6 WEEKS, PENDING CLEARANCE OF INFECTION. DOI: (B)(6) 2016 (PATELLA), DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS), DOE: (B)(6) 2018 (WOUND DEBRIDEMENT), DOE: (B)(6) 2019 (DECOMPRESSION), DOR: (B)(6) 2019 (INSERT EXCHANGE), DOE: (B)(6) 2019 (WOUND DEHISCENCE REPAIR), DOR: (B)(6) 2020 (STAGE 1 REVISION), RIGHT KNEE.

  Patient problems: Edema; Fever; Itching Sensation; No Code Available; Pain; Sepsis; Unspecified Infection

  MAUDE report 10247605 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A RIGHT KNEE BONE DECOMPRESSION TO TREAT PAIN AND WALKING DIFFICULTY SECONDARY TO HETEROTOPIC OSSIFICATION. INTRAOPERATIVELY, THE SURGEON REMOVED ANTERIOR SUPRAPATELLAR BONE SPURS AND ADHESIONS AND PERFORMED A SYNOVECTOMY. ALL COMPONENTS WERE WELL-FIXED AND RETAINED. THE PATIENT RECEIVED AN ANTERIOR ADDUCTOR CANAL NERVE BLOCK CATHETER FOR POSTOPERATIVE PAIN RELIEF. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATHOLOGY OF THE EXCISED TISSUE WAS BENIGN, AND NO INFECTION WAS IDENTIFIED. NO COMPONENTS WERE REVISED. DOI: (B)(6) 2016 (PATELLA), DOI: (B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS), DOE: (B)(6) 2018 (WOUND DEBRIDEMENT), DOE: (B)(6) 2019 (DECOMPRESSION), RIGHT KNEE.

  Patient problems: Adhesion(s); Edema; Extraskeletal ossification; No Code Available; Pain

  MAUDE report 10247521 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVES A RIGHT KNEE SUPERFICIAL INCISION AND DEBRIDEMENT TO TREAT PAIN, SWELLING, AND PURULENT DRAINAGE SECONDARY TO POSTOPERATIVE SUPERFICIAL CUTANEOUS ABSCESS. RADIOGRAPHIC IMAGING IDENTIFIES A WELL-FIXED AND STABLE TC3 REVISION KNEE. THE PROCEDURE WAS DONE IN BY A WOUND CARE SPECIALIST. THE PATIENT IS TO CONTINUE ORAL ANTIBIOTIC TREATMENT. NO PRODUCTS WERE REVISED. DOI: (B)(6) 2016 (PATELLA), DOI:(B)(6) 2018 (INSERT, TIBIAL AND FEMORAL COMPONENTS), DOE: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Abscess; Edema; Fluid Discharge; Impaired Healing; No Code Available; Pain

  MAUDE report 10247207 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REASON FOR REVISION WAS DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9897971 ↗
• InjuryNov 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8120107 ↗
• InjuryOct 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF PFC TC3 COMPONENTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7934807 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT CAME TO SEE THE SURGEON WITH SIGNS OF INFECTION. THE SURGEON DECIDED TO I&D THE KNEE AND CHANGE THE POLY. WHILE PERFORMING THE WASHOUT HE CHANGED THE POLY FROM A 12MM TO 17.5MM FOR MORE STABILITY. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 7510228 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED TOTAL KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7133571 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT WAS COMPLAINING OF LITTLE PAIN IN THE KNEE BUT NO CLINICAL EVIDENCE OF INFECTION. IT WAS STATED THAT SURGEON WENT INTO INSPECT IMPLANTS FOR LOOSENING AND KNEE STABILITY. ALL IMPLANTS WERE WELL FIXED BUT HAD A LITTLE BIT OF LAXITY SO SURGEON ELECTED TO GO UP TO A THICKER POLY INSERT. DOI: (B)(6) 2017 DOR: (B)(6) 2017.

  Patient problems: Pain

  MAUDE report 7120533 ↗
• InjuryOct 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Pain

  MAUDE report 6913386 ↗