P.F.C. SIGMA 1581-14-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295063520), received between Dec 15, 2017 and Feb 23, 2026 — classified as 9 injuries, 1 malfunction.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH A THREE-WEEK HISTORY OF INFECTED RTKR. INITIAL OPERATION ON (B)(6) 2020. PATIENT HAD DAIR WITH CHANGE OF POLY ON (B)(6) 2026. BLOOD TESTS AND XRAY WERE REQUIRED PRE OP. THE OLD POLY WILL BE SENT TO HOSPITAL FOR TESTING AS PER SURGEON'S REQUEST. TISSUE SAMPLES WERE TAKEN INTRAOPERATIVE AND SENT TO HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 24417934 ↗
• InjuryDec 31, 2025Naturally Worn; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR OSTEOLYSIS, POLYWEAR, AND PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 23933313 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAINFUL KNEE AND UNDERWENT REVISION SURGERY FOR FULL REVISION. PRIMARY COMPONENTS REMOVED AND REPLACED WITH SIGMA REVISION TC3 FEMUR WITH SLEEVE AND STEM AND MBT REVISION RP TIBIAL WITH SLEEVE AND STEM. THERE WAS NO SURGICAL DELAY. DOI: UNK DATE 2012. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17730390 ↗
• MalfunctionJan 27, 2023Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT OR RIGHT? THIS INVOLVED THE RIGHT KNEE. B. CAN YOU PLEASE CLARIFY WHAT YOU MEAN BY "DAMAGED" OR "FAULTY"? WAS IT WORN, CRACKED, BROKEN INTO PIECES, BENT, STRIPPED, CROSS-THREADED, OR ANY DEVICE INTERACTION? A LIP OF THE FIXED BEARING INSERT WAS BENT SO THAT IT WOULD NOT FIT INTO THE FIXED BEARING TIBIAL TRAY. C. DID THE EVENT HAPPEN DURING PRIMARY OR REVISION SURGERY? THIS EVENT OCCURRED DURING PRIMARY KNEE REPLACEMENT SURGERY. D. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED SURGICAL DELAY? THERE WERE NO ADVERSE CONSEQUENCES OR SYMPTOMS DUE TO THE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252836 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN I AND D PROCEDURE INCLUDING A POLY SWAP OF HIS RIGHT KNEE AS A RESULT OF SWELLING OF THE KNEE. NO FURTHER INFORMATION AVAILABLE. DOI: 2003. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 16233253 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15902535 ↗
• InjuryMay 7, 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. POLY INSERT UPSIZED. THERE WAS NO SURGICAL DELAY. NOTHING FURTHER TO REPORT. DOI: (B)(6) 2012. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14315476 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE PATELLAR COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. SURGEON TOOK AN X-RAY AND NOTICED THE PATELLA HAD CUT LOOSE AND WAS FLOATING IN KNEE. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12597726 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND FEVER. THE SURGEON BELIEVED THAT THE IMPLANTS WERE PROPERLY POSITIONED AND THE INCISION SITE APPEARED TO LOOK GOOD. UPON OPENING THE KNEE JOINT, THE SURGEON CONFIRMED THAT THE TISSUES LOOKED HEALTHY. HE REMOVED THE SZ 4 12.5MM CVD INSERT, THOROUGHLY WASHED OUT THE JOINT, TRIALED A SZ 4 12.5MM CVD+ INSERT, PERFORMED A SYNOVECTOMY AND INSERTED A REAL IMPLANT. THE LEG WAS RAN THROUGH A FULL RANGE OF MOTION AND WAS FOUND TO BE SATISFACTORY. DOI: (B)(6) 2014. DOR:(B)(6) 2021; LEFT KNEE.

  Patient problems: Fever; Pain

  MAUDE report 11560605 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. IT WAS NOTED UPON REMOVAL THAT THE TISSUE/ BONE APPEARED NECROTIC AND FIBROUS. DOI: (B)(6) 2016; DOR: (B)(6) 2017; UNKNOWN AFFECTED KNEE.

  Patient problems: Pain

  MAUDE report 7120875 ↗