P.F.C. SIGMA 96-1720Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295240051), received between Sep 20, 2018 and Sep 10, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjurySep 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. IT IS INDICATED THE PATIENT WAS EXPERIENCING PAIN PRIOR TO REVISION ON (B)(6) 2019. ALSO, THE SURGEON NOTED THE PATIENT EXPERIENCED EXPECTED ACUTE BLOOD LOSS ANEMIA POST-OPERATIVELY AND RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS TO ADDRESS THE ISSUE.

  Patient problems: Foreign Body Reaction; Injury; Joint Disorder; No Code Available; Pain

  MAUDE report 8982809 ↗
• InjurySep 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PREVIOUS OPERATION. DOI: (B)(6) 2005 (STEM), DOI: (B)(6) 2007 (FEMORAL), DOR: (B)(6) 2009.

  Patient problems: Not Applicable; Pain

  MAUDE report 7895200 ↗