P.F.C. SIGMA 96-2153Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295241416), received between Aug 17, 2018 and Feb 3, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT FEMUR WAS REVISED DUE TO THIGH PAIN. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21294681 ↗
• InjuryMar 26, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP AND PATELLA REVISION. DOI: (B)(6) 2005. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. ADDITIONAL EVENT INFORMATION REPORTS THE REVISION WAS DUE TO WORN POLY ¿ INSTABILITY IN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18978907 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: ON (B)(6) 2023, PATIENT'S LEFT KNEE WAS REVISED WITH COMPLETE EXPLANTATION OF IMPLANTS AND PLACEMENT OF AN ANTIBIOTIC LOADED SPACER (SURESPACE TIBIAL AND FEMORAL COMPONENTS, ALONG WITH 6 PACKAGES OF DEPUY 2 GENTAMYCIN CEMENT AND ADDITIONAL POWDERED VANCOMYCIN (MANUFACTURER UNSPECIFIED) FOR A TOTAL OF 12 GRAMS OF VANCOMYCIN ADDED TO DEPUY 2 CEMENT), TO ADDRESS RECURRENT CHRONIC INFECTION (ADDITIONALLY, AN UNKNOWN MANUFACTURER'S HIGH TIBIAL OSTEOTOMY STAPLE WAS ALSO REMOVED, USING A SEPARATE INCISION). EXPLANTATION OF COMPONENTS CAUSED MINIMAL TO MODERATE BONE LOSS--A NORMAL EXPECTATION OF REVISION SURGERY. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO COMPLICATIONS. THE MEDICAL RECORDS APPEAR TO PROVIDE NO NEW INFORMATION THAT IMPACTS PRIOR PRODUCT AND CODING ASSIGNMENTS, NOR CHANGE THE EXISTING REPORTABILITY DETERMINATIONS.

  Patient problems: Unspecified Infection

  MAUDE report 18463795 ↗
• InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS PAINFUL KNEE. REVISED FEMORAL COMPONENT. UNABLE TO READ NUMBERS ON THE FEMORAL COMPONENT. UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2016. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18246029 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO LOOSE KNEE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6),2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17371965 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS LEFT KNEE REPLACED OVER 20 YEARS AGO ACCORDING TO SURGEON WHERE HE HAD HIS LEFT KNEE REPLACED WITH A SIGMA RP PS TKA CONSTRUCT. 9 DAYS AGO HIS KNEE SWELLED UP AND BECAME SORE. PATIENT CAME TO THE EMERGENCY ROOM WHERE IT WAS DETERMINED THAT THE PATIENT KNEE WAS INFECTED. THE ORIGINAL DATE OF SURGERY, THE SURGEON WHO DID THE SURGERY, EXACT LOCATION, AND THE RESULTS OF LAB TEST ARE UNKNOWN. DOI: OVER 20 YEARS AGO, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Discomfort; Swelling/ Edema; Unspecified Infection

  MAUDE report 16795464 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR RESECTION FOR STAPHYLOCOCCUS MUTIGEN INFECTION. ALL IMPLANTS REMOVED. AN I&D PLOY EXCHANGE WAS PERFORMED ON (B)(6) 2022. DOI: (B)(6) 2016, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16270664 ↗
• InjuryOct 26, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR POLY WEAR. EVENT IS CONSIDERED SEVERE. INFORMATION IS UNAVAILABLE RELATED TO SERIOUSNESS OF EVENT. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2002. DATE OF EVENT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE) TREATMENT: REVISION; INSERT AND PATELLA WERE REVISED.

  Patient problems: Insufficient Information; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15673031 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE PATELLA AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT I&D POLY EXCHANGE WAS PERFORMED DUE TO INFECTION. STAPHYLOCOCCUS MUTIGEN. PATELLA COMPONENT WAS SHEARED OFF FROM THE PEGS AND CONSEQUENTLY REMOVED. PATIENT DID NOT DESCRIBE A FALL OR TRAUMA. DOI: (B)(6) 2016, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15217016 ↗
• InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS INFECTION. SURGEON PERFORMED AN I&D WITH POLYETHYLENE EXCHANGE. THE INSERT THAT WAS REMOVED WAS A SIZE 5 - 15MM RP STABILIZED AND WAS REPLACED WITH A NEW SIZE 5 - 15MM RP STABILIZED INSERT. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12554903 ↗
• InjuryApr 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY EXCHANGE AND DEBRIDEMENT. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11706662 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS STIFFNESS AND DECREASE ROM. SYNOVECTOMY WITH POLY EXCHANGE AND PATELLA REVISION WERE PERFORMED. DOI: (B)(6) 2008, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Muscular Rigidity; No Code Available

  MAUDE report 10444452 ↗
• InjuryJun 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND THE KNEE BECAME UNSTABLE. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Fall; No Code Available

  MAUDE report 10154052 ↗
• InjuryJan 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. I& D WITH POLY SWAP WERE PERFORMED. NO ACCESS TO CONFIRM IF INFECTION WAS PRESENT. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9636455 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS RIGHT KNEE PAIN. TOOK OUT ATTUNE KNEE AND REPLACED WITH MBT TC3. DOI: (B)(6) 2018; DOR: (B)(6) 2019; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 9497749 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS WHICH CAUSED LOOSENING OF THE PATELLA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. REVISED WITH AN EXTENSIVE SYNOVECTOMY AND REPLACED THE PATELLA COMPONENT AND THE INSERT WHILE IN THERE. FEMORAL AND TIBIAL COMPONENTS WERE WELL FIXED. NOTHING WAS BROKEN OR LEFT IN THE PATIENT. SINCE THERE IS NO OP REPORT FROM 2005, THEY DO NOT KNOW WHAT TYPE OF CEMENT WAS USED IN THE ORIGINAL KNEE REPLACEMENT SURGERY.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9443847 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. STATIC SPACER WERE IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2018. UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7792615 ↗