P.F.C. SIGMA 1581-15-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295063667), received between Apr 23, 2021 and Jun 14, 2022 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ITEM 158115115/LOT 8244470 HAS EXPIRED, 31/12/2020 ON THE PACKAGE, ALTHOUGH THE EXP DATE IN THE SYSTEM IS 16/08/2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14685676 ↗
• InjuryJun 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CEMENT IS NOT THE PROBLEM. THE PROBLEM WAS THE PATIENT DID NOT DO PHYSICAL THERAPY AND GOT A STIFF KNEE SO THE DOCTOR PUT A THINNER INSERT IN THE PATIENT SO HE COULD BEND HIS KNEE.

  Patient problems: Joint Contracture; Muscular Rigidity

  MAUDE report 12073119 ↗
• InjuryApr 23, 2021Naturally Worn; Naturally Worn

  THE PATIENT'S KNEE WAS REVISED DUE TO INSTABLE KNEE. PREVIOUS PATELLA TENDON TRANSFER AT YOUNG AGE. OTHER PREVIOUS SURGERIES PRIOR TO ORIGINAL TOTAL KNEE. LIGAMENT LAXITY HYPERTENSION AND POSTERIOR LATERAL POLY WEAR. REVISED 15MM CURVED POLY TO 20MM CURVED PLUS TO GAIN STABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11713205 ↗