SIGMA 96-2351Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295242345), received between Feb 6, 2018 and Jul 30, 2025 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: THE SIGMA TIBIAL INSERT WAS REVISED FOR INFECTION. THE INSERT SHOWS MODERATE YELLOWING.

  Patient problems: Unspecified Infection

  MAUDE report 22668845 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED KNEE, INSERT WAS REPLACED WITH THE SAME SIZE AND KNEE WAS WASHED OUT. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(6), 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20629237 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTED KNEE. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) AND TC3 POLY EXCHANGE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17835520 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION SYMPTOMS. SURGEON SWAPPED INSERT AS PART OF AN IRRIGATION AND DEBRIDEMENT. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17815850 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO TC3 RP W/O ROM, CONVERTED TO NOILES HINGE FOR LIGAMENTOUS STABILITY. COMPETITOR BONE CEMENT WAS USED. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 15845551 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST OP INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14622144 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SOME INSTABILITY SO A LARGER INSERT WAS PUT IN. ORIGINAL IMPLANT DATE UNKNOWN. DOI- UNKNOWN. DOR- (B)(6) 2022. IMPLANTATION DATE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14021123 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. WASH OUT, I&D AND POLY EXCHANGE WERE PERFORMED. DOI: (B)(6) 2021. DOE: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13498468 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO ARTHROFIBROSIS. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2011. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12721270 ↗
• InjurySep 30, 2021Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  DISJOINTMENT OF KNEE PROTHESIS AND RUPTURE OF THE PE INSERT. REVISION SURGERY WAS NEEDED. DOI: UNKNOWN. DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 12554004 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. CONVERT TO ANTIBIOTIC SPACER. A DEPUY CEMENT WAS USED. 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 11820241 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY UNICOMPARTMENTAL KNEE REPLACEMENT ON 25 SEPTEMBER 2018. PATIENT PRESENTED WITH A FRACTURE OF THE TIBIAL PLATEAU - AT THIS POINT THE UNICOMPARTMENTAL KNEE WAS REVISED TO A PFC TC3 RP. PATIENT HAS REPORTED ONGOING PAIN AND DISCOMFORT FROM TIME OF REVISION PROCEDURE. BONE SCANS INDICATE INCREASED UPTAKE AROUND THE TIP OF THE TIBIAL STEM AND AROUND THE RESURFACED PATELLA. A DECISION WAS MADE TO REVISE SOME/ ALL OF THE TC3. ON OPENING THE KNEE, ALL THE COMPONENTS WERE FOUND TO BE WELL FIXED. EXTENSIVE SCARRING/ SCAR TISSUE WAS FOUND AROUND THE INFERIOR POLE OF THE PATELLA COMPONENT - THIS WAS EXCISED. THE TIBIAL TRAY AND STEM WERE REMOVED LEAVING THE TIBIAL SLEEVE IN SITU. THE SLEEVE WAS AGAIN CHECKED TO ENSURE IT WAS WELL FIXED. AN ALTERNATIVE TRAY WAS IMPLANTED INTO THE FIXED TIBIAL SLEEVE, BUT THIS TIME WITHOUT A STEM. THE VIEW BEING THAT THE SLEEVE IS WELL FIXED AND THE LOAD WOULD TRANSFER THROUGH THE SLEEVE - THE STEM WOULD THEN NOT BE REQUIRED AND WOULD ALSO PREVENT LOADING AROUND THE TIP OF THE STEM, WHICH HAD POTENTIALLY CAUSED THE PAIN. A NEW BEARING WAS IMPLANTED AND THE KNEE CLOSED.

  Patient problems: Adhesion(s); Discomfort; Pain

  MAUDE report 11813760 ↗
• InjuryFeb 15, 2021Noise, Audible; Noise, Audible

  THE PATIENT WAS REVISED TO ADDRESS CRUNCHING AND POPPING OF THE KNEE. SURGEON ALSO NOTICED SOME GLOBAL INSTABILITY. SURGEON PERFORMED THOROUGH SYNOVECTOMY ALONG WITH POLY EXCHANGE TO THICKER INSERT. DOI: (B)(6) 2019, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11328072 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I&D AND INSERT EXCHANGE WERE DONE. DOI: UNKNOWN. DOR: (B)(6) 2020. UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10804459 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 THE PATIENT UNDERWENT A MEDIAL UNICOMPARTMENTAL TOTAL KNEE TO ADDRESS THE PREOPERATIVE DIAGNOSIS OF MEDIAL COMPARTMENT OSTEOARTHRITIS, RIGHT KNEE. NO COMPLICATIONS NOTED. MEDICAL RECORDS FROM (B)(6) 2019 NOTED THAT SINCE THE REVISION ON (B)(6) 2016, THE PATIENT HAS EXPERIENCED PAIN AND SWELLING, EFFUSION, AND HAS HAD AN ASPIRATION PERFORMED. SURGEON NOTED A CONCERN FOR LOOSENING OF COMPONENTS, AS WELL AS OSTEOLYSIS VERSUS POSSIBLE INFECTION. RADIOGRAPHS WERE REPORTED TO SHOW POSSIBLE LOOSENING. AT THE TIME OF THIS REVIEW, THERE WERE NO REVISION INFORMATION.

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 10514623 ↗
• MalfunctionJun 30, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SIZE 4-10 MM RP TC3 INSERT HAD A HAIR ON IT. DOE: JUN 17, 2020, LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213078 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  PATIENT FELL , THE POST WAS IN PLACE . THERE WAS NO SPIN OUT . THEY THOUGHT THE TRAY MAY HAVE BEEN LOOSE SINCE SHE FELL AND IT WASN¿T . DON¿T KNOW WHEN SURGERY WAS FIRST DONE YEARS AGO FROM THE SURGEON AT JFK . NO INSTRUMENTS BROKEN OR DELAYS OF SURGERY BASED ON PRODUCT .

  Patient problems: Fall; Joint Disorder; No Code Available

  MAUDE report 9653290 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON CALLED FOR IMPLANTS TO PERFORM A POLY SWAP ON (B)(6) 2019. DOI: UNKNOWN DOR: (B)(6) 2019 UNKNOWN KNEE SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9586728 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD FEMORAL REVISION FOR INFECTION AND LOOSENING OF COMPONENT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9401577 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE AND I&D WERE DONE. DOI: UNKNOWN; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8920904 ↗
• InjuryAug 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RE REVISION OF KNEE ARTHROPLASTY. PATIENT CONSEQUENCE? :UNKNOWN PATIENT CONSEQUENCE DESCRIPTION:PAIN AND DIFFICULT TO WALK. ACTION TAKEN FOR PROCEDURE:CULTURES TAKEN, IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: Pain

  MAUDE report 7741937 ↗
• InjuryFeb 6, 2018Naturally Worn; Naturally Worn

  DER STATES THAT WHEN REMOVING 4/10MM TC3 RP POLY, THE SURGEON OBSERVED UNUSUAL WEAR ON THE POLY SURFACE. DOI: UNKNOWN. DOR: (B)(6) 2018. UNKNOWN KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7243731 ↗