SIGMA 96-2363Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295242512), received between Jul 5, 2018 and Sep 10, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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. 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.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO INFECTION. ALL PARTS WERE EXPLANTED AND A CEMENT SPACER FROM A DIFFERENT VENDOR WAS IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23016538 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FEMUR REVISION. POSTOPERATIVELY, PATIENT BECAME INFECTED. SURGEON OPENED KNEE, DEBRIDED AND WASHED OUT AFTER REMOVING POLY. IMPLANTED SAME POLY THAT WAS REMOVED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22370830 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SIZE 5/15MM TC3 RP INSERT WAS REMOVED FOR INFECTION AND REPLACED WITH A NEW ONE OF THE SAME SIZE. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20711039 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED BECAUSE OF IRRIGATION AND DEBRIDEMENT DUE TO INFECTION WITH POLY EXCHANGE. THERE WAS NO LOOSENING. NO DELAY. DOI:(B)(6) 2020. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19086721 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED TOTAL KNEE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18365153 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WAS DONE. DOI: (B)(6) 2018. DOR: (B)(6) 2021. LEFT KNEE.

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

  MAUDE report 11859668 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OFFICE NOTES ''(B)(6) 201'' - (B)(6) 2019 INDICATE THE PATIENT IS EXPERIENCING SWELLING, POPPING, INSTABILITY AND PAIN OF THE LEFT KNEE. HE IS ALSO EXPERIENCING SWELLING, PAIN, NUMBNESS AND INSTABILITY IN THE RIGHT KNEE AND FEELINGS OF CRUNCHING AND CRACKING. CURRENT TREATMENT INCLUDES ORAL PAIN MEDICATION, PHYSICAL THERAPY, KNEE BRACES AND NERVE BLOCKS. NO EVIDENCE OF ADDITIONAL REVISION OF PRODUCTS. DOI: ''(B)(6) 201'', (TRAY - CAPTURED IN (B)(4)). DOI: (B)(6) 2019, (FEMUR, PATELLA AND INSERT - CAPTURED IN (B)(4)). DOR: NONE REPORTED; RIGHT KNEE.

  Patient problems: Joint Laxity; Numbness; Pain; Swelling/ Edema

  MAUDE report 11728147 ↗
• InjuryApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. NO LOOSENING REPORTED. NO SURGICAL DELAY. DOI: (B)(6) 2018, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11634091 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH ONSET OF PAIN BEGINNING ON SUNDAY (B)(6). PATIENT WAS BROUGHT TO OR UNDER A PREMISE OF A ACUTE INFECTION. A THOROUGH I&D WAS PREFORMED WITH POLY EXCHANGE AND PLACEMENT OF ANTIBIOTIC BEADS. SURGEON DID NOTE SOME INSTABILITY SO A THICKER INSERT WAS PLACED. DOI: (B)(6) 2016. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity; Pain

  MAUDE report 11582587 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REVISION SURGERY WAS FOR INSTABILITY. AT THIS TIME DR. REMOVED ALL PRIMARY COMPONENTS AND IMPLANTED A PFC TC3 RP REVISION SYSTEM. PATIENT HAS NOW PRESENTED WITH PAIN AROUND THE KNEE AND THE FEELING OF INSTABILITY (AND SOMETIME FEELS THE KNEE IS HYPEREXTENDING. A DECISION WAS MADE TO OPEN THE KNEE AND CONFIRM A DIAGNOSIS. ON OPENING THE KNEE, ALL COMPONENTS WERE FOUND TO BE WELL FIXED. THERE WAS SOME LAXITY THROUGH THE RANGE OF MOTION AND A DECISION WAS MADE TO UPSIZE THE POLY INSERT FROM A SIZE 15MM TO A 20MM THEREBY MAKING THE KNEE MORE STABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 10214588 ↗
• InjuryMay 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10034196 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10029975 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SOME LAXITY. POLY WAS EXCHANGED TO TIGHTEN UP THE KNEE. A DEPUY CEMENT WAS USED. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9890980 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. WASH OUT SURFACE WAS DONE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9811750 ↗
• InjuryJan 3, 2020Adverse 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: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9545578 ↗
• InjuryDec 20, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO SIGNIFICANT WEAR ON THE POLY; SURGEON ALSO TRIED REGAINING MORE FLEXION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT KNEE.

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

  MAUDE report 9504781 ↗
• InjurySep 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. A BONE SCAN WAS COMPLETED AND SHOWED NO SIGNS OF COMPONENT LOOSENING. PLAN WAS TO REPLACE THE POLY. SURGEON CHANGED THE POLY FROM A 15 TO A 17.5 AND IT APPEARED TO HAVE TIGHTENED UP THE INSTABILITY. NO SIGNS OF INFECTION. PATIENT WENT TO RECOVERY WITH A FULL RANGE OF MOTION FROM FLEXION TO EXTENSION. DOI: (B)(6) 2018; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9078733 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8780516 ↗
• InjuryApr 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE WAS PERFORMED. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8562384 ↗
• InjuryJul 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS PAIN, LOOKING FOR INFECTION AND NO EVIDENCE OF INFECTION. POLY SWAP WAS DONE. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 7663964 ↗