P.F.C. SIGMA 96-2111Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295241102), received between Sep 7, 2017 and Aug 13, 2026 — 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.

• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient poly was revised for more stability.DOI- Unknown.DOR- (b)(6) 2026.Affected side- Right knee.

  Patient problems: Joint Laxity

  MAUDE report 50242128 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24271087 ↗
• InjuryDec 9, 2025Adverse 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. POSTERIOR LATER WEAR ON INSERT. UNKNOWN LOT NUMBERS. SURGEON REMOVED FEMUR, TIBIA, INSERT.

  Patient problems: Joint Laxity

  MAUDE report 23756274 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO REPORTED PATIENT HARM AND SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 20555761 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6), 2017. DOR: (B)(6), 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20401433 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH FEMUR DUE TO PAIN. FEMUR WAS WELL FIXED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17809581 ↗
• InjuryJan 5, 2023Naturally Worn; Naturally Worn

  KNEE REVISION ON FRIDAY (B)(6) - WASH OUT AND POLY EXCHANGE. SURGEON FOLLOWED UP OLD RECORDS AND WAS ABLE TO CONFIRM ORIGINAL IMPLANT DETAILS WITH ME 19/12. DR AT PINDARA IS BOTH THE ORIGINAL HOSPITAL AND SURGEON, AS WELL AS THE REVISION CASE ORIGINAL SURGERY (B)(6) 2008. RIGHT KNEE REVISION - PATIENT PRESENTED FEELING LIKE ¿KNEE WAS LOCKING UP¿ AFTER CASE SURGEON PREDICTS IT IS RELATED TO THE MCL AND PERHAPS SOME EARLY STAGE POLY WEAR THE POLY LINER WAS EXCHANGED FOR A NEW ONE AND THE KNEE WAS WASHED OUT AND CLOSED DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? --> UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT. PINDARA PRIVATE, WAS DEVICE EXPLANTED? FALSE, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. (B)(6) 2022, REASON FOR REVISION SURGERY. DESCRIBED ABOVE , PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 16104264 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CHANGE OF A TOTAL PFC PS RP PROSTHESIS WHICH WAS PAINFUL. NO SIGNS OF LOOSENING. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 14454088 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. IRRIGATION AND DEBRIDEMENT. POLYETHYLENE EXCHANGE. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13733179 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REPOST PATIENT WAS DOING WELL BUT HAD FALLEN TWO YEARS AFTER HER ORIGINAL SURGERY. WENT TO A THICKER POLY AFTER DETERMINING THAT THE FEMUR AND TIBIA WERE WELL FIXED. DOI: (B)(6) 2018. DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12575726 ↗
• InjurySep 11, 2020Naturally Worn; Unintended Movement; Noise, Audible; Naturally Worn; Unintended Movement; Noise, Audible

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA TKA. IT WAS REPORTED THAT THE PATIENT TOLD SOMETHING UNUSUAL TO THE SURGEON WHEN FOLLOW-UP IN (B)(6) 2020. THE SURGEON CONFIRMED SPIN-OUT BY X-RAY. AN ABNORMAL SOUND WAS HEARD WHEN BEND AND STRETCH, AND THE PATIENT COULD NOT BEND AND STRETCH SMOOTHLY. THE PATIENT ALSO HAD SUBLUXATION AT ANKLE JOINT. THE PATIENT RESTS WITH SPIN-OUT NOW. THE SURGEON THOUGHT THAT THE SPIN-OUT WAS NOT CAUSED BY THE IMPLANTS AT THIS STAGE, THE REASON OF SPIN-OUT WAS UNKNOWN. HE PLANNED TO REPLACE THE TIBIAL INSERT FOR FIRST-LINE CHOICE, OR TO REPLACE THE TIBIAL INSERT AND THE TIBIAL TRAY FOR SECOND-LINE CHOICE SINCE HE PLANNED TO USE A FB TIBIAL INSERT. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 10521909 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10133789 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PREVIOUS MEDIAL CONDYLE FRACTURE AND PAINFUL KNEE. INFECTION WAS NEGATIVE. NO LOT NUMBERS FOR IMPLANTS. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9795036 ↗
• InjuryFeb 19, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  SMARTSET GHV GENTAMICIN BONE CEMENT CLAIM LETTER RECEIVED. CLAIM LETTER ALLEGED PAIN, DISCOMFORT, INSTABILITY, DIFFICULTY AMBULATING CAUSED BY ASEPTIC LOOSENING. DOI: (B)(6) 2016; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Discomfort; Edema; Fatigue; Foreign Body Reaction; Hypoesthesia; Inflammation; No Code Available; Pain

  MAUDE report 9727974 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8551811 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS BILATERAL INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8551756 ↗
• InjurySep 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6847829 ↗