SIGMA 96-2361Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295242482), received between Jun 26, 2017 and Aug 6, 2026 — classified as 23 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Unspecified Infection

  MAUDE report 50168311 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POLY SWAP AND WASH OUT. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24132543 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH KNEE WASHOUT DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21148926 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING. THE CEMENT MANUFACTURER WAS COMPETITOR. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20223145 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON DID A WASHOUT WITH LINER EXCHANGE IN AN INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(4) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18310555 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT AS THIS WAS A REVISION PROCEDURE (WASHOUT AND POLY CHANGE DUE TO INFECTION), THERE WAS NO SURGICAL DELAY OR EXTENSION. AFFECTED OR OPERATIVE SIDE CONFIRMED FROM KIT DIARY: RIGHT SIDE.

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

  MAUDE report 11929729 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION AND REMOVAL OF ALL PREVIOUS REVISION COMPONENTS. REVISION WAS REQUIRED DUE TO INFECTION BEING PRESENT WITH SWELLING AND FLUID WITHIN THE KNEE. DOI: UNKNOWN; DOR: (B)(6) 2021; UNKNOWN KNEE.

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

  MAUDE report 11887095 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION DUE TO WOUND DEHISCENCE DOI: (B)(6) 2021 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 11589954 ↗
• InjuryJan 28, 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. IMPLANTS WERE WELL FIXED, TC3 INSERT WAS INCREASED TO A 17.5MM INSERT, MULTIPLE SCARRING AND ADHESIONS WERE REMOVED/RELEASED. CULTURES TAKEN ON (B)(6) 2021 WERE NEGATIVE, NO INFECTION. PATIENT PREVIOUSLY RECEIVED KNEE REVISION ON (B)(6) 2016 AFTER MULTIPLE TKA INFECTIONS. DOI: (B)(6) 2016, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 11243931 ↗
• 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 AND ALL IMPLANTS WERE REMOVED. THE PATIENT HAS MULTIPLE HEALTH ISSUES INCLUDING CANCER. THE PATIENT BEGAN TO HAVE AN ISSUE WITH THE KNEE APPROXIMATELY 3 MONTHS AGO AND BY THE TIME HE CAME IN, HE WAS GROSSLY INFECTED WITH A DRAINING SINUS. A STATIC SPACER WAS PLACED AFTER THOROUGH I&D. DOI: (B)(6) 2013, DOR: (B)(6) 2020, LEFT KNEE.

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

  MAUDE report 11117752 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Code Available; Pain

  MAUDE report 10621500 ↗
• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION TOTAL KNEE REPLACEMENT ON (B)(6) 2014 ( HOSPITAL). AT THIS STAGE A PFC TC3 RP SYSTEM WAS UTILIZED WITH A TABECULAR METAL PATELLA COMPONENT FROM ZIMMER BIOMET. PATIENT HAS REPORTED AND ONGOING NIGGLE AND HAS NOT BEEN TOTALLY SATISFIED WITH THE OUTCOME. PATIENT HAS RECENTLY PRESENTED WITH A PAINFUL KNEE. THE CRP WAS REVIEWED AND CAME BACK WITH AN ELEVATED READING INDICATING A KNEE INFECTION. A DECISION WAS MADE TO OPEN THE KNEE AND PERFORM A WASHOUT AND BEARING EXCHANGE ON (B)(6) 2020. ON OPENING THE KNEE, THERE WERE NO OBVIOUS SIGNS OF INFECTION. MULTIPLE SOFT TISSUE SAMPLES WERE TAKEN, THE KNEE DEBRIDED AND WASHED OUT AND NEW POLY BEARING IMPLANTED. IT WAS NOTED THAT THE KNEE WAS A LITTLE LOOSE SO THE 10MM BEARING THAT HAD BEEN REMOVED WAS REPLACED WITH A 15MM BEARING.

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

  MAUDE report 10536532 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS EXPLANTED AND A KASM ANTIBIOTIC SPACER WAS IMPLANTED. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE. HERE ARE THE FINAL 4 EXPLANTED IMPLANTS: 96-0901, LOT #D39FB4, 96-0901, LOT #H19755, 96-0908, LOT #HH7455, 96-0908, LOT # H08683. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9637178 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED RIGHT REVISION TKR, WASHOUT AND POLY EXCHANGE: SURGEON: (B)(6), (B)(6) 2020. THE PATIENT UNDERWENT REVISION TOTAL KNEE REPLACEMENT USING SIGMA TC3, ON (B)(6) 2012. PRESENTED TO THE SURGEON WITH SIGNS OF INFECTION. PROCEDURE PERFORMED WAS A DEBRIDEMENT WASHOUT AND EXCHANGE OF INSERT. EXISTING SIZE 5, 10MM INSERT WAS REMOVED AND REPLACED WITH A NEW INSERT OF THE SAME SIZE AND THICKNESS. THE SURGEON STATED THERE WERE SOME SIGNS OF LYSIS BEHIND THE FEMORAL PROSTHESIS, HOWEVER, HE STATED THAT THE COMPONENTS REMAINED WELL FIXED AND STABLE AT THIS TIME.

  Patient problems: No Code Available; Osteolysis; Unspecified Infection

  MAUDE report 9608157 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE PATIENT WAS BROUGHT TO THE SURGERY FOR KNEE PAIN AND LYTIC LESION APPARENT ON X-RAY. DISCOVERED INTRA-OPERATIVELY SIGNS OF METALLOSIS WITH LYTIC LESIONS WITH PSEUDO TUMOR BONE LOSS AT THE DISTAL FEMUR. IT WAS DISCOVERED THAT METALLOSIS WERE ORIGINATED AT THE FEMORAL ADAPTER BOLT AND UNIVERSAL FEMORAL SLEEVE INTERFACE. METAPHYSEAL AND UNIVERSAL SLEEVES CONTINUE TO BE WELL FIXED. BACK TABLE PHOTOS AND PRE-OPERATIVE X-RAYS AVAILABLE UPON REQUEST. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis; Pain

  MAUDE report 9207785 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND STIFFNESS. DOI: (B)(6) 2016, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9139718 ↗
• InjuryJun 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION. A WASHOUT AND POLYETHYLENE INSERT EXCHANGE OCCURRED. DOI: UNKNOWN, DOR: (B)(6) 2018, (RIGHT KNEE). DEVICE: SIGMA TIBIAL INSERT TCIII RP CVD SZ 5 10MM.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8662986 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY PERFORMED ON (B)(6) 2018. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT INFECTION ON THE PATIENT¿S KNEE ON (B)(6) 2018. SINCE THE SURGEON COULD NOT CONTROL THE INFECTION, IMPLANTS WERE EXPLANTED FROM THE PATIENT'S KNEE JOINT DUE TO POSTOPERATIVE INFECTION, AND CEMENT SPACER WAS PLACED IN THE PATIENT'S KNEE JOINT FOR TREATMENT THE KNEE JOINT INFECTION ON (B)(6) 2018. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 7868287 ↗
• InjuryJul 30, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT UNKNOWN INTERFACE DUE TO INFECTION. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7733076 ↗
• InjuryMay 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION. POLY INSERT WAS SWAPPED OUT. DOI: UNKNOWN. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7521568 ↗
• InjuryApr 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT PATIENT IS GROWING STAPH AND ECOLI. WASHED OUT KNEE AND PUT IN A NEW POLY. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7442499 ↗
• InjuryJul 21, 2017Fracture; Fracture

  PATIENT WAS REVISED TO ADDRESS INSTABILITY, DISLOCATION, PAIN AND BROKEN SPINE ON PS INSERT.

  Patient problems: Pain

  MAUDE report 6731466 ↗
• InjuryJun 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATED THAT THE PATIENT HAD PRIMARY TKA ON BOTH SIDES 2 YEARS AGO BUT HAS EXPERIENCED CHRONIC EFFUSIONS ON BOTH KNEES SINCE PRIMARY SURGERY. PATIENT RTKA WAS REVISED ON (B)(6) 2017. HE DID PERFECTLY WELL FOR 8 DAYS ON THE 9TH DAY HE EXPERIENCED ACUTE SWELLING AND APPARENT INFECTION. SURGEON ELECTED TO I&D WITH POLY EXCHANGE ON (B)(6) 2017. HE ELECTED TO REMOVE ALL IMPLANTS ON (B)(6) 2017 AND IMPLANT ANTIBIOTIC BEADS, SPACER AND LOOSELY CEMENTED PRIMARY CR ATTUNE FEMUR, LOOSELY CEMENTED PSRP INSERT WITH TOP POST REMOVED. SURGEON IS AWARE THIS IS OFF LABEL BUT FELT IT WAS THE BEST INTEREST OF THE PATIENT.

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 6666641 ↗