P.F.C. SIGMA 96-2113Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295241126), received between Sep 14, 2020 and Jul 21, 2021 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12204430 ↗
• InjurySep 14, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND SUBLUXATION. THE SURGEON DECIDED TO REMOVE HER PRIMARY KNEE AND REPLACE WITH A MORE CONSTRAINED KNEE PROSTHESIS. THE SURGEON REMOVED THE ORIGINAL COMPONENTS AND REPLACED WITH ATTUNE REVISION IMPLANTS WITH SLEEVE AND STEMS. NO ONE MENTIONED A PROBLEM WITH THE ORIGINAL IMPLANTS BUT DID NOTICE THE POLY LOOKED WORN ON THE POSTERIOR SIDE BOTH MEDIAL AND LATERAL SIDES. THEY WERE ABLE TO RECOVER COMPONENT SIZES BUT THE HOSPITAL BUYS THEIR OWN CEMENT SO THEY DO NOT KNOW THE MANUFACTURER. DOI: (B)(6) 2013 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10530981 ↗