SIGMA 1960-65-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295075318), received between May 29, 2018 and Jan 28, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. HE HAS SIGMA RP'S ON BOTH KNEES AND A SHOULDER REPLACEMENT AS WELL. ASPIRATION OF THE KNEE GREW C ACNES. PATIENT EXPERIENCING PAIN. SURGEON WAS REMOVING THE LEFT TKA TODAY AND REPLACING WITH A SPACER (ATTUNE CR FEMUR WITH ATTUNE CR RP INSERT CEMENTED INTO THE TIBIA). ACTIVITY LEVEL - YES. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21253265 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION OF JOINT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20662631 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR; (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18124123 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A COMPLETE REVISION WAS DONE SINGLE STAGE. THERE WAS NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14985936 ↗
• InjuryFeb 9, 2021Adverse 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, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11300802 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A TKA ON (B)(6) 2019 WHICH BECAME INFECTED. ON (B)(6) 2019 HE HAD ALL IMPLANTS REMOVED AND A SPACER PLACED. THE SPACER WAS A FEMUR IMPLANT AND INSERT CEMENTED INTO PLACE. THE SPACER WAS PLACED AND A TC3 REVISION KNEE WAS PLACED. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9591178 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT PRESENTED WITH ANTERIOR PAIN AND MID-FLEXION INSTABILITY. REMOVED TIBIAL INSERT, FEMORAL AND TIBIAL COMPONENTS. BOTH FEMORAL AND TIBIAL COMPONENTS APPEARED SOLIDLY FIXED UPON GROSS EXAMINATION, AND REQUIRED EXTENSIVE USE OF OSTEOTOMES AND MINI-SAWS TO LOOSEN FOR REMOVAL. ALTHOUGH THE TIBIAL TRAY SHOWED LITTLE CEMENT ATTACHMENT ON THE UNDERSIDE UPON REMOVAL (PICTURES ATTACHED), I CANNOT TELL IF THAT WAS A RESULT OF THE USE OF THE OSTEOTOMES AND SAWS. THE FEMORAL COMPONENT EXHIBITED SIGNS OF CEMENT ATTACHMENT, ALTHOUGH EXPOSURE DID NOT ALLOW FULL EXPLORATION OF THE UNDERSIDE OF THE FEMORAL IMPLANT. RE-IMPLANTED SIZE 5 TC-3 FEMORAL WITH 2 EACH 4 MM POSTERIOR AUGMENTS, AND SHORT CEMENTED STEM, MBT WITH 30 MM CEMENTED STEM AND 53 MM METAPHYSEAL SLEEVE, AND A 15 MM TC-3 INSERT. DOI: (B)(6) 2017; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7548773 ↗