P.F.C. SIGMA 1581-22-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295064169), received between Sep 15, 2017 and Aug 11, 2026 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient was revised due to Knee pain. Possible infection.Activity Level - Yes.DOI: Unknown.DOR: Unknown.Affected Side: Left Knee.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50216229 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLAINED OF UNSTABLE KNEE AND WAS REVISED TO AN S-ROM HINGE KNEE DUE TO MEDICAL COLLATERAL LAXITY. NO EXPLANATION FOR LAXITY OF THE MCL LIGAMENT APPARENT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17142674 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES: (B)(6) 2012 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT WAS UTILIZED X2. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES: (B)(6) 2014 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO LOOSE TOTAL KNEE ARTHROPLASTY. UPON ENTERING THE JOINT, SYNOVITIS AND SCAR TISSUE WAS ENCOUNTERED AND REMOVED. THE FEMORAL COMPONENT WAS LOOSE AS WELL AS THE FEMORAL TIBIAL COMPONENT ¿ INTERFACE NOT PROVIDED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2012, DOR: (B)(6) 2014, RIGHT KNEE.

  Patient problems: Adhesion(s); Synovitis

  MAUDE report 12122742 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AT HOME AND NEEDED AN I & D, LINER EXCHANGE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Fall; No Code Available

  MAUDE report 10191583 ↗
• MalfunctionNov 6, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  A TIBIAL INSERT SHAPE WAS MODIFIED, IT COULD NOT BE IMPACTED, THEREFORE IT WAS NOT IMPLANTED. PATIENT STATUS, OUTCOME, CONSEQUENCES: NO.

  Patient problems: Not Applicable

  MAUDE report 9284278 ↗
• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REPORTED TO ADDRESS PAIN. DOI: UNKNOWN. DOE: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8730477 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNK; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8623592 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT RECEIVED FOR SURGICAL SITE PAIN AND LIMB SWELLING.

  Patient problems: Pain; Swelling

  MAUDE report 8239851 ↗
• InjuryAug 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE PATIENT HAD BILATERAL TOTAL KNEE ARTHROPLASTY. THE FIRST SURGEON REVISED FEMUR ON THE RIGHT SIDE, WHILE THE SECOND SURGEON DID THE SAME ON THE LEFT SIDE AS IT IMPROVED PAIN ON THE RIGHT SIDE POST REVISION. DOI: (B)(6) 2017; DOR: B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7777615 ↗
• InjuryJan 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN; DOR: (B)(6) 2017; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7178048 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. TIBIA TRAY WAS HOT ON BONE SCAN. UPDATE 11-23-2017: BONE SCAN (B)(6) 2017 REVEALS AN ASYMMETRIC INCREASED PERIPROSTHETIC RADIOTRACER ACTIVITY INVOLVING THE LEFT KNEE JOINT. PRE-OPERATIVE OFFICE NOTES (B)(6) 2017 INDICATES THE PATIENT PRESENTS WITH EVIDENCE OF ASEPTIC LOOSENING IF THE TIBIAL COMPONENT. AT THIS TIME, A REVISION NOTE HAS NOT BEEN PROVIDED, THEREFORE, IT IS UNKNOWN IF THE TIBIAL COMPONENT WAS LOOSE. FOLLOW UP WILL BE INITIATED FOR THIS. CURRENTLY, THERE IS NO NEW INFORMATION THAT WOULD IMPACT MDR REPORTABILITY.

  Patient problems: Pain

  MAUDE report 7044633 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 7042240 ↗
• MalfunctionSep 15, 2017Product Quality Problem; Product Quality Problem

  DER STATES THAT THERE WERE NO IMPLANT STICKERS INSIDE THE IMPLANT BOX.

  Patient problems: No Information

  MAUDE report 6868635 ↗