P.F.C. SIGMA 96-2135Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295241287), received between Nov 17, 2017 and Jul 22, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND POLY EXCHANGE DUE TO INFECTIONS. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6)2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19794532 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S TIBIAL INSERT WAS REVISED DUE TO INSTABILITY. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 18543774 ↗
• MalfunctionOct 24, 2023Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping; Incomplete or Missing Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ITEM'S PACKAGING WAS INADEQUATE / THOUGHT THE INNER SEAL WAS COMPROMISED. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995555 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WERE PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17725979 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS NO PRESENCE OF INFECTION.

  Patient problems: Fluid Discharge

  MAUDE report 12392367 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7040782 ↗