SIGMA 97-0471Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295250678), received between Jul 6, 2018 and Apr 24, 2023 — 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.

• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A POLY SWAP, AND WAS WORRIED THE KNEE MAY BE INFECTED. KNEE WAS WASHED OUT. DOI: UNKNOWN. DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16795138 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D WAS PERFORMED WITH POLY EXCHANGE. NO SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16550465 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL, AND HAD AN INCISIONAL DEHISCENCE. SURGEON DID A WASHOUT IN A POLY SWAP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16246888 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE OPEN INCISION. THE DOCTOR DID A WASHOUT AND A POLY SWAP. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 16246858 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. NO INDICATION OF A PROBLEM WITH THE PRODUCTS. DOI: (B)(6) 2021. DOR; (B)(6) 2021 RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12962823 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FALL WHILE DOING SQUATS. THE POLYETHYLENE INSERT WAS REVISED FROM A 5X10MM INSERT TO A 5X12.5MM INSERT. THE REASON FOR THE POLY EXCHANGE WAS THE PATIENT WAS A LITTLE LOOSE IN FLEXION AND EXTENSION. WANTED TO GO UP A SIZE DUE TO THE LIGAMENTS BEING STRETCHED FROM THE FALL. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9641834 ↗
• InjuryJul 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PRIMARY RIGHT TKR ON (B)(6) 2017. PATIENT PRESENTED TO SURGEON IN OFFICE WITH PAINFUL INSTABILITY. ORIGINAL KNEE WAS CR SIGMA, 5 FB MOD TIB TRAY, CVD + INSERT 5/10MM AND 41 PATELLA. SURGEON UPSIZED POLY TO A 5/15MM CVD + AND CLOSED KNEE FOLLOWING GOOD ROM. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7666107 ↗