P.F.C. SIGMA 96-0720Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295233763), received between Apr 14, 2021 and Jun 11, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A HIP SURGERY, THE FEMORAL STEM BOLT COULDN¿T BE TIGHTENED. IT WAS THOUGHT THAT THE PROBLEM WAS IN THE THREAD OF THE FEMORAL STEM. BOLT WAS WORKING WELL, WHEN THEY TRIED TO TIGHTEN IT IN ANOTHER FEMUR STEM IT GOT TIGHTENED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183363 ↗
• MalfunctionAug 27, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  FEMORAL STEM BOLT COULD NOT BE TIGHTENED DURING THE SURGERY. THE PROBLEM WAS IN THE THREAD OF THE FEMORAL STEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075181 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE 1ST CLEANING OF THE AFFECTED AREA DUE TO INFECTION AFTER PRIMARY SURGERY. THIS PC REPORTS A SECOND CLEANING OF THE AFFECTED AREA AND REVISION OF THE IMPLANT AFTER THE FIRST CLEANING OF THE AFFECTED AREA. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE PRIMARY SURGERY. AT THE END OF 2023 (DATE UNKNOWN) BECAUSE INFECTION WAS SUSPECTED, THE PATIENT WAS TREATED FOR CLEANING OF THE AFFECTED AREA. ON AN UNKNOWN DATE, THE MCL (MEDIAL COLLATERAL LIGAMENT) WAS CONFIRMED TO BE OPEN. AND THE PATIENT ORIGINALLY HAD MALIGNANT RA. THEREFORE, ON MAR 18, THE AFFECTED AREA WAS CLEANED, AND THE IMPLANTS WERE FINALLY REMOVED AND REPLACED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 18978519 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CLEANING AND RE-REVISION SURGERY AFTER THE CONFIRMATION OF INFECTION. THIS PC REPORTS THE PAIN AND INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE REASON FOR THE REVISION IS UNKNOWN. AFTER THE REVISION SURGERY, ON (B)(6) 2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; (B)(6) 2022 DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116853 ↗
• InjuryApr 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FROM THE THE PROVIDED PHOTOS AND RETURNED DEVICES, IT WAS DETERMINED THERE WAS NO ADAPTER USED WITH THE FEMORAL CONSTRUCT. INSTEAD THE CONSTRUCT INVOLVED THE STEM BOLT AND STEM ASSEMBLY WHERE NO ADAPTER IS USED FOR THIS CONFIGURATION. NO PREVIOUS REVISION WAS INVOLVED. UNCOMPLICATED SURGERY USING STANDARD TECHNIQUE AND TORQUE LIMITING DEVICE TO ATTACH STEM. STANDARD SURGICAL TIME (NOT EXTENDED). IT WAS THE LEFT SIDE INVOLVED IN THIS EVENT. NO TRAUMA TO KNEE AT ANY TIME POST SURGERY. CEMENT PRODUCT WAS NOT FROM DEPUY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction

  MAUDE report 11664914 ↗