P.F.C. SIGMA 1581-24-108Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295064480), received between Aug 31, 2017 and Feb 17, 2026 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Naturally Worn

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY. PATIENT IMPLANTS WERE ALL WELL FIXED. SURGEON SAID THEY HAD STANDARD POLY WEAR AND JUST NEEDED TO HAVE THEIR INSERT EXCHANGED. A SIZE 4, 8MM STABILIZED INSERT WAS TAKEN OUT, AND SURGEON WENT BACK IN WITH A SZ 4, 8MM XLK STABILIZED POLY. ONCE IMPLANTED, STABILITY OF THE KNEE WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. THERE WERE NO DELAYS OR ADVERSE EVENTS. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369270 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A KNEE WASH OUT (NO DEFINED ONSET POSSIBLE FROM FALL A YEAR PRIOR AND A PATELLA FX) WITH A POLY SWAP.

  Patient problems: Fall

  MAUDE report 22577261 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SWELLING AND DRAINING WAS REPORTED. WASH OUT DONE AND POLY WAS SWAPPED, DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fluid Discharge; Swelling/ Edema

  MAUDE report 21597340 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 17741127 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO WOUND DEHISCENCE. IT WAS UNKNOWN IF ANY LOOSENING OCCURRED. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED. DOI: (B)(6) 2022 DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Wound Dehiscence

  MAUDE report 15666148 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT FOR INFECTION. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13891186 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTED TOTAL KNEE. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED IN. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13177849 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED SEVERAL INFECTIONS FOLLOWING TKA. REVISION WAS COMPLETED. KNEE WAS WASHED OUT AND A NEW POLY WAS INSERTED. DOI: (B)(6) 2009, DOE: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13170934 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LEFT KNEE PAIN. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12532038 ↗
• InjuryJul 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH MINOR POSTERIOR MEDIAL WEAR AND HAD SLIGHT WEAR ON HIS PATELLA. SURGEON REMOVED INSERT AND REPLACED WITH THE SAME SIZE INSERT AND DECIDED INTRAOP TO REPLACE THE PATELLA TOO WITH THE SAME SIZE. ALL PARTS WERE WELL. DOI: (B)(6) 2011. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12143426 ↗
• MalfunctionJun 1, 2021Difficult to Insert; Difficult to Insert

  LEFT KNEE REPLACEMENT. FB TIBIAL INSERT - SURGEON NOTICED THAT THE IMPLANTED WAS NOT SEATED PROPERLY AND THE LOCKING DEVICE WAS NOT ENGAGED. REMOVED AND USED A NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11915638 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TKR- PATIENT HAD A FALL ON KNEE 18 MONTHS POST PRIMARY TKR. SIX WEEKS AFTER FALL PATIENT STARTED EXPERIENCING PAIN AND INSTABILITY

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 11065965 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. THE PATIENT PRESENTED TO THE DOCTOR WITH A REDDISH AND SWOLLEN KNEE. AN I&D WITH POLY SWAP WAS DONE. DOI: (B)(6) 2020. DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: Edema; No Code Available; Unspecified Infection

  MAUDE report 10649715 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED TKA. EXPLANTED ALL COMPONENTS WITH CEMENT SPACER IMPLANTATION. DOI: (B)(6) 2019, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10303137 ↗
• MalfunctionJan 24, 2020Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  PCF SIGMA COMP WAS ON INSERTION OF THE POLY IT WOULD NOT SEAT DUE TO SOFT TISSUE IMPAIRMENT. AFTER SEVERAL ATTEMPTS, SURGEON REQUESTED A NEW POLY BE OPENED. HE STATES THE TABS AT THE FRONT OF THE POLY ARE WEAKER IN THE XLK AND STRONGER IN THE PREVIOUS MATERIAL. 10 MINUTES DELAY. NO AE REPORTED. ACTION TAKEN: NEW TIBIAL INSERT OPENEND AND PUT INTO PATIENT.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 9628729 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2018: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X2. PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. (B)(6) 2019: THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE REPORTS OF PAIN, STIFFNESS, EDEMA, OBSERVABLE 5 DEGREES KNEE FLEXION CONTRACTURE AND SUSPECTED LOOSENING. INTRAOPERATIVE FINDINGS WERE EFFUSION AND SYNOVITIS ALONG WITH LOOSE TIBIAL TRAY AT IMPLANT-CEMENT INTERFACE. PATELLA AND FEMORAL COMPONENT NOT REVISED. ALL OTHER COMPONENTS (TIBIAL TRAY AND INSERT) WERE REPLACED WITH DEPUY REVISION SYSTEM WITH DEPUY CEMENT. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. DOI: (B)(6) 2018; DOR: (B)(6) 2019 (TIBIAL TRAY AND INSERT).

  Patient problems: Edema; No Code Available; Pain

  MAUDE report 9547971 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE SURGEON AGREED TO PERFORM A SYNOVECTOMY AND INSPECT ALL IMPLANTS TO INSURE NO ISSUES. UPON SURGERY, HE FOUND THE KNEE WELL BALANCED TO BE WELL BALANCED AND WELL FIXED. HE THEN DECIDED TO CHANGE POLY TO HELP PREVENT ANY RISK OF INFECTION.

  Patient problems: No Code Available; Pain

  MAUDE report 8619441 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8271630 ↗
• InjuryApr 17, 2018Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS PATELLAR PAIN AND ABNORMAL POLY WEAR. IT WAS ALSO REPORTED THAT THE SURGEON REPLACED THE TIBIAL INSERT WITH SAME SIZE AND REPLACED PATELLA WITH A BIOMET DOME PATELLA. DOI: (B)(6) 2017. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7436204 ↗
• InjuryNov 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 7038153 ↗
• InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS REPAIR OF RETINACULAR. IT WAS STATED THAT THERE WAS AN I&D AND POLY SWAP DONE. UPDATE AUG 11, 2017: ADDITIONAL INFORMATION RECEIVED. THE SURGEON VERBALLY CONFIRMED THAT THERE WAS INFECTION. THIS COMPLAINT WAS UPDATED ON AUG 15, 2017.

  Patient problems: Unspecified Infection

  MAUDE report 6835471 ↗