SIGMA 96-2336Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295242178), received between Sep 13, 2017 and Oct 11, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2019. DOR: (B)(6) 2021. (RIGHT KNEE).

  Patient problems: Pain

  MAUDE report 12605261 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9707168 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION, I&D. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2014; DATE OF EVENT (ONSET): (B)(6) 2019; (RIGHT KNEE).

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

  MAUDE report 9706413 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SCAR TISSUE LIMITING FLEXION: ADHESIONS; PATELLAR CLUNK; INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT THERE IS A REMOTE POSSIBILITY IT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2017. DATE OF EVENT: (B)(6) 2019. DATE OF REVISION: (B)(6) 2019. (RIGHT KNEE). PRODUCTS PRESENT AT THE TIME OF THE AE: CATALOG: 962336. LOT: H42734. DESCRIPTION: SIGMA TIBIAL INSERT TCIII RP CVD SZ 2.5 22.5MM. CATALOG: 960848. LOT: H44566. DESCRIPTION: SIGMA WDG POSTERIOR 8MM SZ 2.5. CATALOG: 960841. LOT: EG1AF4. DESCRIPTION: SIGMA WDG DISTAL 4MM SZ 2.5 RT. CATALOG: 960841. LOT: 143934. DESCRIPTION: SIGMA WDG DISTAL 4MM SZ 2.5 RT. CATALOG: 960092. LOT: H48846. DESCRIPTION: SIGMA FEM TCIII CEMENTED RT SZ 2.5. CATALOG: 129453215. LOT: 745018. DESCRIPTION: UNIVERSAL SLEEVE DISTALLY POROCOAT SZ 31MM. CATALOG: 129435315. LOT: C72656. DESCRIPTION: MBT REVISION TIBIAL TRAY. CATALOG: 129454000. LOT: H31933. DESCRIPTION: MBT REVISION TIBIAL SLEEVE 29MM. CATALOG: 960781. LOT: H69611. DESCRIPTION: SIGMA FEMORAL ADAPTER 5 DEGREE. CATALOG: 960784. LOT: H53353. DESCRIPTION: SIGMA FEMORAL ADAPTER BO

  Patient problems: Adhesion(s); Loss of Range of Motion; No Code Available; Pain; Scar Tissue

  MAUDE report 9082389 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2016, DOR: (B)(6) 2019 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8443907 ↗
• InjuryOct 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6948967 ↗
• InjurySep 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION. IT WAS ALSO INDICATED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 6861933 ↗