P.F.C. SIGMA 96-2062Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295241010), received between May 20, 2022 and Oct 31, 2023 — 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.

• InjuryOct 31, 2023Naturally Worn; Naturally Worn

  OPERATIVE NOTES REVIEWED. ON (B)(6) 2023 THE PATIENT HAD A REVISION LEFT TOTAL KNEE REPLACEMENT TO ADDRESS WEAR OF THE ARTICULAR BEARING SURFACE, INTERNAL DERANGEMENT OF LEFT KNEE. IT WAS NOTED THAT THE PATIENT HAD LIGAMENTOUS LAXITY AND THERE WAS A MINIMAL AMOUNT OF FOREIGN BODY SYNOVITIS. THE PATELLA WAS NOTED TO HAVE SMALL AMOUNT OF WEAR, BUT WAS FOUND TO BE SATISFACTORY AND RETAINED. ONLY THE INSERT WAS REVISED. THE OPERATIVE FINDINGS INCLUDED POLYETHYLENE WEAR TIBIAL COMPONENT AND PATELLA COMPONENT. DEPUY INSERT WAS IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Insufficient Information; Joint Laxity; Synovitis

  MAUDE report 18039675 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY CR150 MBT TKJA IN SITU - IMPLANTED (B)(6) 2017, PATIENTS HAS CONSISTENTLY COMPLAINED ABOUT PAIN AND INSTABILITY. ON X-RAY - IMPLANTS APPEAR WELL FIXED WITH SOME FOREIGN LOOSE BODIES NOTED POSTERIOR KNEE AND NATIVE PATELLA - FEMUR AND TIBIA APPEAR IN VARUS POSITION AND FEMUR HAS FLEXED. PLAN WAS TO OPEN AND REMOVE LOOSE BODIES AND RESURFACE PATELLA WITH ? FULL ATTUNE REVISION PRIMARY IMPLANTS EXPLANTED AND FULL ATTUNE REVISION PERFORMED. FEMUR - SIZE 8 RIGHT WITH 18X60MM PRESSFIT STEM AND 40MM PARTIALLY COATED SLEEVE. 4MM DISTAL AUGMENTS MEDIALLY AND LATERALLY. TIBIA - SIZE 7 REVISION RP BASE WITH 14X60MM PRESSFIT STEM, 37MM PARTIALLY COATED SLEEVE POLY - 8/10MM REVISION INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 14462530 ↗