P.F.C. SIGMA 1581-13-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295063407), received between Dec 12, 2017 and Jun 5, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Expiration Date Error” (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.

• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SIGMA IMPLANTS WERE IMPLANTED IN (B)(6) OF 2011. PATIENT WAS HAVING KNEE PAIN. CONSTRUCT WAS REPLACED WITH ATTUNE REVISION IMPLANTS. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25413978 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LINER EXCHANGE FOR INSTABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23437855 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 15155920 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY DATE OF IMPLANTATION: (B)(6) 2012. DATE OF REVISION: (B)(6) 2021 (LEFT KNEE). TREATMENT: FEMUR AND TIBIAL INSERT REVISED.

  Patient problems: Joint Laxity

  MAUDE report 11840937 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS DEALING WITH SOME MID FLEXION INSTABILITY THAT STARTED ROUGHLY ABOUT A YEAR AGO. DR. HAD PLANNED TO PERFORM AN I&D POLY EXCHANGE, INCREASING POLY THICKNESS AND CHANGING IT TO A CURVED PLUS INSERT. ONCE THE KNEE WAS OPEN, DR. REALIZED THE TIBIAL COMPONENT WAS LOOSE AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. HE OPTED TO REMOVE THE TIBIA, REAM FOR A 14X75 STEM, AND IMPLANT A SIZE 3 REVISION TIBIA WITH A 37 TIBIAL SLEEVE. WITH LEAVING THE FEMUR, HE TRIALED RP CURVED INSERTS AND FOUND THE SZ 4 17.5MM INSERT YOU BE SATISFACTORY. ALL THE IMPLANTS WERE OPENED AND IMPLANTED. THE KNEE WAS RUN THROUGH A RANGE OF MOTION AND FOUND TO BE STABLE. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2017, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10816078 ↗
• MalfunctionMar 30, 2020Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT ON OCTOBER 8, 2019, A PRODUCT WITH AN EXPIRATION DATE OF (B)(6) 2019 WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900779 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS TOO TIGHT SO HE PUT IN THINNER POLY. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 9588146 ↗
• InjurySep 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS SWOLLEN KNEE POSSIBLE PUS. SURGEON PERFORMED I AND D AND REPLACED POLY WITH SAME SIZE 3 X 12.5 CVD AND CLOSED. DOI: (B)(6) 2018. DOR: (B)(6) 2018; UNKNOWN KNEE.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 7905945 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HER RIGHT KNEE REPLACED IN 2015 AT (B)(6). SHE RECENTLY BEGAN EXPERIENCING PAIN AND DISCOMFORT IN HER KNEE. SURGEON SEEN THE PATIENT AND DETERMINED THAT HER KNEE WAS MOST LIKELY INFECTED AND WOULD REMOVE THE IMPLANTS. ALL COMPONENTS WERE EXPLANTED AND NEW COMPONENTS WERE IMPLANTED AFTER A THOROUGH I&D. DOI: (B)(6) 2015, DOR: (B)(6) 2018, RIGHT KNEE.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 7722234 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT INITIATED FORM RECEIVED. AS VERBALIZED BY PATIENT "I CALLED IN BECAUSE OF A RECALLED PRODUCT IMPLANTED IN MY RIGHT KNEE. I WAS REVISED BECAUSE OF THE LOOSE KNEE, PAIN AND I CANNOT MOVE/DO ANYTHING. AND I WILL BE HAVING A SECOND SURGERY." I ASKED THE PATIENT FOR THE PRODUCT INFORMATION. PROVIDED THE INFORMATION ABOUT THE AUTHORIZATION LETTER, PATIENT UNDERSTOOD. ASKED FOR FURTHER ASSISTANCE, PATIENT DECLINED. DOI: (B)(6) 2016 ; DOR: (B)(6) 2017 (RIGHT KNEE).

  Patient problems: Pain

  MAUDE report 7109350 ↗