P.F.C. SIGMA 96-2051Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295240914), received between Mar 21, 2018 and Apr 30, 2026 — classified as 33 injuries.

The most frequently reported specific device problem is “Naturally Worn” (9 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED WITH POLY EXCHANGE FOR THICKER INSERT. THERE WAS NOTHING WRONG WITH POLY, KNEE JOINT WAS JUST A LITTLE TOO LOOSE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 25046101 ↗
• InjuryMar 26, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION, WASH OUT WAS PERFORMED, POLY POST HAS BROKEN OFF. THERE WAS LOOSENING OF SIZE 5 10MM POLY AT UNKNOWN INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 24706860 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24570519 ↗
• InjuryDec 30, 2025Naturally Worn; Naturally Worn

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION FOR LOOSENING OF THE FEMORAL COMPONENT, TIBIAL COMPONENT, AND PAIN THE NON-ARTICULAR SURFACE OF THE REVISED CEMENTED TIBIAL TRAY SHOWS NO CEMENT REMAINING, AND RELATIVE MOTION BETWEEN BONE AND METAL. THE NON-ARTICULAR SURFACE OF THE MOBILE-BEARING POLYETHYLENE TIBIAL INSERT SHOWS SEVERE ABRASION. THE ARTICULAR SURFACE DEMONSTRATES SEVERE ABRASION, PITTING, AND DELAMINATION.

  Patient problems: Pain

  MAUDE report 23923196 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY EXCHANGE DUE TO INFECTION. DOI: (B)(6) 2007. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22346634 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS SEVERE ARTHROFIBROSIS & HETEROTOPIC OSSIFICATION. IMPLANTS WERE NOT LOOSE. PRODUCTS WERE REMOVED BECAUSE THE PATIENT HAD LIMITED ROM. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 22211024 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21346097 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTE AD 27 NOV 2024 REVIEWED BY A CLINICIAN. THE PATIENT PRESENTS AT A FOLLOW-UP APPOINTMENT. HE PREVIOUSLY HAD BILATERAL TOTAL KNEE REPLACEMENTS 17 YEARS AGO. 2 WEEKS PRIOR, THE PATIENT WAS RISING FROM A SEATED POSITION AND FELT A TWINGE IN HIS RIGHT KNEE WITH SOME MEDIAL BASED PAIN AND SWELLING. THE PATIENT HAS DIFFICULTY WALKING. A KNEE ASPIRATION WAS COMPLETED AND SENT FOR CULTURE AND HE WAS GIVEN A PROPHYLACTIC DOSE OF ANTIBIOTICS. HOWEVER, IT IS STATED "THIS IS MOST LIKELY A PINCH OF HIS SYNOVIUM." THE SYNOVIAL FLUID DID HAVE SOME BLOOD THAT WILL GO AWAY ON ITS OWN.

  Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 20777653 ↗
• InjurySep 9, 2024Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO LOOSENING OF THE PATELLA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT PATIENT CAME IN WITH A SIGMA CR RP PRESSFIT IMPLANT. DURING SURGERY, IT WAS FOUND THAT PATELLA POLY AND ARTICULATING POLY WERE SEVERELY DELAMINATED WHERE THE METAL OF FEMUR AND TIBIA WERE RUBBING TOGETHER, CAUSING BLACK NECROTIC TISSUE BEING REMOVED, AS WELL AS THE POLY AND PATELLA. DOI: UNKNOWN. DOR: (B)(6), 2024. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Necrosis

  MAUDE report 20169455 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR POSSIBLE INFECTION. JUST A POLY WAS SWAPPED AND THE SAME SIZE WAS USED. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18807424 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR LARGE EFFUSION; DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2024. DATE OF EVENT: UNK JAN 2024 (RIGHT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT AND REVISION; INSERT WAS REVISED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 18543960 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY SWAPPED FOR INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18541794 ↗
• InjuryFeb 16, 2023Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED FOR STABILITY AND UNDERWENT A POLY EXCHANGE. IT WAS REPORTED THAT THERE WAS POSTERIOR MEDIAL WEAR. SAME THICKNESS WAS REIMPLANTED AND STABLE. DOI: (B)(6) 2006. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16386264 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR CONTINUED PAIN AND LIMITED ROM. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2022, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: ASPIRATION/DRAINAGE (ASPIRATE SENT FOR SYNVASURE AND CULTURE) AND ORAL MEDICATION

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 15851996 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. THERE WAS NO LOOSENING EXPERIENCED AND THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15380385 ↗
• InjuryAug 30, 2022Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2009. DATE OF REVISION: (B)(6) 2022. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, INSERT, AND PATELLA REMOVED.

  Patient problems: Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 15319500 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD I&D POLY EXCHANGE DUE TO INFECTION. NO LAB RESULTS WERE THERE AT THE TIME OF SURGERY. NO SURGICAL DELAY. DOI: (B)(6) 2008; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 14564574 ↗
• InjuryJan 31, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2011, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF FEMUR AND TIBIAL INSERT; PATELLA WAS RESURFACED DURING REVISION; TIBIAL TRAY AND TIBIAL SLEEVE WERE RETAINED.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 13394429 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATED THE FOLLOWING: A. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? B. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? C. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? ANSWERS: A) NO. B) NO. C) NO.

  Patient problems: Joint Laxity

  MAUDE report 12518444 ↗
• InjurySep 16, 2021Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  MEDICAL RECORDS REVIEWED AND INDICATED THAT ON (B)(6) 2009, PATIENT RECEIVED BILATERAL PRIMARY TOTAL KNEE REPLACEMENTS, USING J&J SIGMA INGROWTH FEMURS AND TIBIAL TRAYS, WITH CR RP TIBIAL INSERTS AND CEMENTED PATELLAR BUTTONS. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2021, PATIENT PRESENTED IN CLINICAL SETTING WITH SEVERE PAIN, STIFFNESS, AND HEMARTHROSIS OF THE RIGHT KNEE. THIS WAS A SUDDEN ONSET EVENT, WHEREBY PATIENT WENT TO THE EMERGENCY ROOM. A KNEE ASPIRATION WAS ATTEMPTED BY THE ER WITHOUT SUCCESS. HE DEMONSTRATED SOME VARUS VALGUS LAXITY IN THE CLINIC OFFICE, AS WELL AS DIFFICULTY FLEXING MORE THAN 45 DEGREES DUE TO PAIN AND SWELLING. IT WAS DIAGNOSED AS BEARING SPINOUT. CLINICAL PA WAS ABLE TO ASPIRATE 45 ML BLOOD FROM KNEE, WHICH WAS SENT FOR CULTURES. ON (B)(6) 2021, PATIENT'S RIGHT KNEE WAS REVISED TO ADDRESS PAIN, RECURRENT HEMARTHROSIS SECONDARY TO BEARING SPINOUT. INTRAOPERATIVELY, IT WAS DISCOVERED THAT THE PATIENT ALSO HAD PATELLAR BUTTON DELAMINATION, WITH MULTIPLE FRAGMENTS OF POLYETHYLENE DEBRIS THROUGHOUT THE KNEE JOINT. THERE WAS ALSO EXTENSIVE SYNOVITIS, LIKELY SECONDARY TO THE POLYETHYLENE DEBRIS. THE KNEE WAS WASHED OUT AND FRAGMENTS REMOVED. THE PAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Joint Laxity; Loss of Range of Motion; Muscular Rigidity; Pain; Swelling/ Edema; Synovitis

  MAUDE report 12481388 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE WAS LOOSE IN FLEXION AND EXTENSION SO A THICKER POLY WAS IMPLANTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12215122 ↗
• InjuryMay 25, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TIBIAL INSERT WAS WORN. NO SURGICAL DELAY. DOI: (B)(6) 2006, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11880617 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LACK OF FLEXION AND EXCESSIVE SCAR TISSUE. NO SURGICAL DELAY. DOI: (B)(6) 2003. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 11879296 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY SWAP WAS PERFORMED ON A PATIENT WHO COMPLAINED OF PAIN AND JOINT LAXITY. 10MM RP CVD INSERT WAS REMOVED, 12.5MM RP CVD INSERT WAS IMPLANTED. LEFT SIDE AFFECTED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 11506746 ↗
• InjuryOct 16, 2020Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  ON (B)(6) 2004, THE PATIENT UNDERWENT A PRIMARY LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2020, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO PAIN, DISCOMFORT, AND DIFFICULTY WALKING. DURING THE EXAM THE PHYSICIAN NOTED LEFT KNEE STIFFNESS. X-RAY IMAGING REVEALED EITHER A SPUN BEARING OR A WORN OUT BEARING ON THE LEFT. THE IMAGING ALSO SHOWED THE FEMUR SUBLUXED LATERALLY AND ANTERIORLY ON THE CROSS TABLE LATERAL VIEW AND THE PATELLA TILTS MEDIALLY SIGNIFICANTLY. IT WAS NOTED DURING THE EXAM ON (B)(6) 2020, THE PATIENT STATED THAT HE DRANK TOO MUCH BEFORE HIS KNEE STARTED FEELING BAD, EITHER FELL OR PASSED OUT, AND SPENT PROBABLY A NUMBER OF WEEKS IN THE HOSPITAL AND THEN FOUR OR SIX WEEKS IN REHAB. SINCE THEN, THE PATIENT HAD NOT BEEN ABLE TO WALK ON HIS LEFT KNEE, PAINFUL, AND THE PATIENT THOUGHT THAT THE KNEE WAS SHIFTING OR THE PATELLA WAS SHIFTING. ON (B)(6) 2020, THE PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS THE POLYETHYLENE WEAR AND RELATED ISSUES. THE TIBIAL INSERT AND THE FEMUR COMPONENTS WERE BOTH REVISED.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Fall; Muscular Rigidity; No Code Available; Pain; Synovitis

  MAUDE report 10689737 ↗