P.F.C. SIGMA 1581-23-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295064329), received between Nov 10, 2017 and May 9, 2025 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE INSERT BOX WAS OPENED FROM INSIDE THE PRODUCT WAS IN OPEN CONDITION/UNSTERILE.

  Patient problems: Insufficient Information

  MAUDE report 21994764 ↗
• MalfunctionFeb 16, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING THE PROCEDURE AN 8MM SIZE 3 INSERT WAS REQUESTED AND WHEN IT WAS OPENED IT WAS REPORTED THAT IT WAS MISSHAPEN ACCORDING TO THE SURGEON. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16384879 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D POLY EXCHANGE WAS PERFORMED DUE TO INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14680341 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2007, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13651919 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 23 JUL 2021. PATIENT HAD A UNKNOWN DEPUY SIGMA SYSTEM IMPLANTED. ON (B)(6) 2019, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY PRODUCTS WERE IMPLANTED, PATELLA WAS RESURFACED, AND UNKNOWN CEMENT WAS UTILIZED. PRIMARY PRODUCT INFORMATION CAN BE FOUND ON PAGE 73 OF THE MEDICAL RECORDS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, THE PATIENT UNDERWENT A LEFT KNEE REVISION TO ADDRESS INFECTION. AT EVALUATION VISITS PRIOR TO REVISION, THE PATIENT WAS EXPERIENCING PAIN, SWELLING, AND DECREASED RANGE OF MOTION. THE SURGEON NOTED SYNOVITIS, SOFTENING OF THE BONE, AND A SMALL ABSCESS IN THE PATELLA THAT WAS DEBRIDED. THE TIBIAL INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT WERE REVISED. THERE IS NO EVIDENCE THE PATELLAR COMPONENT WAS REVISED. THE SURGEON PLACED AN ANTIBIOTIC SPACER AND THE PATIENT RECEIVED IV ANTIBIOTICS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12336158 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE INFECTION. I&D AND POLY EXCHANGE OF RIGHT KNEE WAS DONE. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11831967 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTED LEFT KNEE. REMOVAL OF IMPLANTS AND INSERTION OF CEMENT SPACER PERFORMED. NO LOOSENING REPORTED. NO DELAY DURING SURGERY. DOI: UNKNOWN DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11821201 ↗
• MalfunctionOct 22, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY LINER WOULD NOT SEAT IN TIBIAL TRAY. LOOKS LIKE THE ANTERIOR LOCKING TABS BENT. MAY HAVE BEEN TOO AGGRESSIVE WITH MALLET. OPENED ANOTHER INSERT AND IT WORKED FINE. SURGERY DELAYED BY 45 SECONDS. LINER IS INTACT AND BEING RETURNED TO CORPORATE. NO OTHER INFORMATION AVAILABLE. DOE: (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10719595 ↗
• InjurySep 1, 2020Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS SOFT TISSUE IMBALANCE AND POLY WEAR. DOI: 20 YEARS AGO, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10477277 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS ACUTE HEMATOMA AND PROGRESSED TO INFECTION. SURGEON PERFORMED A POLY EXCHANGE WIT IRRIGATION AND DEBRIDEMENT. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Hematoma; No Code Available; Unspecified Infection

  MAUDE report 10110736 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE, COMPETITOR CEMENT WAS USED.

  Patient problems: Joint Laxity; No Code Available; Pain

  MAUDE report 9510799 ↗
• InjuryOct 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8025034 ↗
• InjuryAug 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-JUN-2018: INFORMATION RECEIVED FROM COLLEAGUE THE PATIENT HAD HER KNEE IMPLANTED 7 YEARS AGO. SHE HAS HAD TROUBLE WITH IT FROM THE BEGINNING. PATIENT IS CURIOUS IF HER KNEE HAS BEEN RECALLED. NO REVISION HAS BEEN REPORTED. DOI: 2011; DOR: UNKNOWN; (UNKNOWN KNEE).

  Patient problems: Joint Disorder; Pain

  MAUDE report 7789251 ↗
• InjuryMay 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE WOUND PAIN, IMPROVED AFTER MULTIPLE TREATMENT MEASURES AFTER SURGERY, CERTAINLY RELATED TO SURGERY. DOI:UNKNOWN DOR: (B)(6) 2018 UNKNOWN AFFECTED SIDE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7514843 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7017725 ↗