P.F.C. SIGMA 96-2152Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295241393), received between Nov 4, 2017 and Mar 3, 2026 — classified as 35 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ASPIRATED PUS IN KNEE, TIBIAL POLY REPLACED AFTER I&D. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Fluid Discharge

  MAUDE report 24498378 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS HAVING A SLIGHT INSTABILITY BILATERALLY. A PATELLA REVISION AND POLY EXCHANGE PERFORMED BILATERALLY. NO DELAYS, NO ADVERSE PATIENT CONSEQUENCES. DOI: ON (B)(6) 2009, DOR: ON (B)(6) 2025, AFFECTED SIDE- RIGHT KNEE. (B)(6) ARE RELATED PC, (B)(4) IS THE MOTHER PC AND (B)(4) IS THE DAUGHTER PC. DAUGHTER PC IS CREATED TO CAPTURE IMPLANT FOR RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23730592 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. THE PATIENT UNDERWENT I&D WITH POLY EXCHANGE. THE PRIMARY SURGERY WAS DONE IN 2015. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23415453 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR UNSTABLE KNEE. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21775401 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION IN BOTH KNEES. POLYS WERE SWAPPED FOR NEW ONES OF THE SAME SIZE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2013. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21459097 ↗
• InjuryJan 28, 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 INFECTION. HE HAS SIGMA RP'S ON BOTH KNEES AND A SHOULDER REPLACEMENT AS WELL. ASPIRATION OF THE KNEE GREW C ACNES. PATIENT EXPERIENCING PAIN. SURGEON WAS REMOVING THE LEFT TKA TODAY AND REPLACING WITH A SPACER (ATTUNE CR FEMUR WITH ATTUNE CR RP INSERT CEMENTED INTO THE TIBIA). ACTIVITY LEVEL - YES DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21253342 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL TKA. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 21025859 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO WASHOUT/POLY SWAP FOR SURGEON SUSPICION OF INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18820630 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY DONE IN 2007. PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON REMOVED A 5X12.5 POLY AND REPLACED WITH A 15MM POLY. DOI: 2007 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 18751377 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT KNEE. POLY WAS DOWNSIZED. DOI: 2009, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 18689167 ↗
• InjuryApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16662834 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS INSTABILITY ISSUES. SURGICAL DELAY WAS UNKNOWN. DOI-UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14354160 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE SEVENTH REVISION FOR THIS PATIENT, PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168131 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ARTHROFIBROSIS AND INSTABILITY. POLY WAS UPSIZED FROM A 12.5MM TO A 17.5MM. DOI: UNKNOWN DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 12131429 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS FAILED LEFT TOTAL KNEE ARTHROPLASTY AND LOOSE LEFT TOTAL KNEE ARTHROPLASTY. THE INDICATIONS FOR SURGERY INCLUDED: ONE BAG OF DEPUY CEMENT USED FOR BOTH KNEES DURING INITIAL IMPLANTATION, WHICH LED TO EARLY FAILURE AND HAS HAD A PREVIOUS REVISION FOR LOOSE TIBIAL. PRIOR MEDICAL RECORDS NOTED THE PATIENT WAS EXPERIENCING INSTABILITY, AND PAIN. DURING THE CURRENT REVISION THE SURGEON REPORTED THAT THE FEMORAL COMPONENT AND PATELLA WERE LOOSE, NO INTERFACE PROVIDED DEPUY FEMORAL COMPONENT, PATELLA, AND INSERT, ALONG WITH COMPETITOR CEMENT X2 WERE USED DURING THIS PROCEDURE. DOI: UNKNOWN, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11619494 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS TO CAPTURE THE EVENT REPORTED IN (B)(4). ON (B)(6) 2017, THE PHYSICIAN ASPIRATED 16 ML FROM THE RIGHT KNEE TO RULE OUT INFECTION. THE PHYSICIAN INDICATED HE DID NOT THINK THE FLUID APPEARED INFECTED. THERE IS NO EVIDENCE OF REVISION FOLLOWING THE RIGHT QUADRICEP TENDON REPAIR. THERE IS NO EVIDENCE OF CONFIRMED INFECTION WITHIN THE AVAILABLE MEDICAL RECORDS. DOI: (B)(6) 2016, DOE: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 11392288 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FAILED LKNEE IMPLANT. PAIN AND OSTEOLYSIS.

  Patient problems: Osteolysis; Pain

  MAUDE report 11066018 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS/BILLING RECORDS WERE REVIEWED: ON (B)(6) 2018, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSENING TIBIAL TRAY AT THE IMPLANT/CEMENT INTERFACE, PAIN, EFFUSION, CLUNKING AND INABILITY TO PERFORM HIS NORMAL FUNCTION. THE FEMORAL COMPONENT WAS NOTED TO BE LOOSENED ¿WAS CLEANED AND RE-CEMENTED¿, THE PATELLA WAS NOTED TO BE WELL FIXED AND WAS RETAINED. ON (B)(6) 2018, THE PATIENT HAD A REVISION LEFT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT THE CEMENT/IMPLANT INTERFACE, PAIN, SWELLING, AND DIFFICULTY WITH WALKING. THE PATELLA AND FEMORAL COMPONENTS WERE NOTED TO BE WELL-FIXED AND WERE RETAINED. THE INSERT WAS REMOVED WITHOUT ALLEGATION OF DEFICIENCY. (STICKER PAGE 46 OF 97) DEPUY TIBIAL TRAY AND INSERT WERE USED AS WELL AS COMPETITOR CEMENT X2 WERE USED DURING THIS PROCEDURE. ON (B)(6) 2019, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS LOOSE RIGHT TOTAL KNEE. THE INDICATIONS FOR SURGERY INCLUDED THAT THE PATIENT HAD A PREVIOUS REVISION FOR ASEPTIC LOOSENING OF HIS TIBIAL PLATEAU. THE PATIENT NOW HAS LOOSENING OF THE FEMORAL COMPONENT AS WELL AS THE PATELLAR COMPONENT, SEVERE POPPING AND SNAPPING AN

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Local Reaction; Pain

  MAUDE report 11037669 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION IN THE LEFT KNEE. SURGEON REMOVED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. LOT NUMBERS WERE COVERED BY CEMENT, UNREADABLE. DOI: UNKNOWN. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9938173 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SIGNIFICANT AMOUNT OF SCAR TISSUE IN THE KNEE. THE SURGEON REMOVED SCAR TISSUE AND EXCHANGED THE INSERT. DOI: UNKNOWN. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9825368 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2011. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9548197 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT 2ND RIGHT KNEE REVISION FOR A POLYETHYLENE SWAP DUE TO INSTABILITY AND PAIN. THE SURGEON INDICATED DEBRIDEMENT WAS PERFORMED OF EXTENSIVE TISSUE IN THE MEDIAL SIDE OF THE JOINT DUE TO MEDIAL LAXITY. THE PATIENT WAS IMPLANTED WITH THE PATIENT IMPLANTED WITH DEPUY KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED. PRODUCT INFORMATION CAN BE FOUND ON PAGE 14/19 OF THE ATTACHED MEDICAL RECORDS. DOI: (B)(6) 2015 (PATELLA); DOI: (B)(6) 2016 (ALL OTHER IMPLANTS); DOR: (B)(6) 2018 (RIGHT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9519746 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE. THE SURGEON UPSIZED INSERT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9511018 ↗
• InjuryDec 19, 2019Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO POLY WEAR AND OSTEOLYSIS OF BOTH INSERT AND PATELLA. DOI: (B)(6) 2005. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Not Applicable; Osteolysis

  MAUDE report 9497499 ↗
• InjuryNov 8, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENTS HAD A POLY WEAR ON BOTH THE INSERT AND THE PATELLA. REVISION INCLUDED A POLY SWAP TO ONE SIZE THICKER INSERT AND A NEW 41 OVAL DOME PATELLA. DOI: (B)(6) 2007; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9297357 ↗