P.F.C. SIGMA 1581-22-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295064091), received between Sep 1, 2017 and Jul 17, 2025 — classified as 15 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (6 reports).

51 other recalls cover devices cleared under the same FDA submission (K033272, K241000); they may or may not involve this specific model.

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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND IRRIGATION AND DEBRIDEMENT WITH A POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22534548 ↗
• InjuryJun 26, 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 NEAR IMPLANT. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22337805 ↗
• MalfunctionDec 9, 2024Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WERE NO PATIENT CONSEQUENCES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878974 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A LEFT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE AN INFECTED KNEE. THE POLY WAS SWAPPED OUT. THERE WAS NO SURGICAL DELAY. DOCTOR IS PERFORMING A CULTURE SWAB. ORIGINAL IMPLANT DATE WAS ON (B)(6) 2015.

  Patient problems: Unspecified Infection

  MAUDE report 20531937 ↗
• MalfunctionJun 20, 2024Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE INSERT WAS NOT USED. THE ANTERIOR BUMPER WAS DAMAGED AND WOULD NOT LOCK INTO TIBIAL TRAY. PATIENT NOT AFFECTED. SURGERY WAS DELAYED 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574004 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO IRRIGATION & DEBRIDEMENT. POLY EXCHANGE WAS PERFORMED. DOI: (B)(6) 2019. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16945758 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION POLY EXCHANGE AND WASHOUT FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16101501 ↗
• InjuryOct 18, 2022Naturally Worn; Naturally Worn

  REVISION COMPLETED DUE TO POLY WAS WORN. SURGEON REPLACED THE POLY. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2007, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15625833 ↗
• MalfunctionJul 20, 2022Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  UPON IMPLANTATION, TIBIAL INSERT WAS NOT COMPLETELY FLUSH LATERALLY LEAVING SPACE BETWEEN THE TIBIAL TRAY AND THE INSERT. OPERATED KNEE IS RIGHT. SURGEON DECIDED TO CHANGE INSERT SIZE TO 10MM BUT SAME ISSUE WAS OBSERVED. FINAL DECISION WAS TO IMPLANT SIZE 10 EVEN WITH THE PROBLEM INVOLVED. FEAR OF INSERT DISLOCATION AND BACKSIDE WEAR REMAINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065635 ↗
• InjuryNov 19, 2021Adverse 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 PAINFUL RIGHT KNEE. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12843192 ↗
• MalfunctionOct 4, 2021Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION RECEIVED INDICATED THE FOLLOWING: 1. WERE THERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS. 2. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? 3. WAS THE PRODUCT IMPLANTED USING DEPUY SYNTHES¿S ATTUNE FEMUR FIRST ANATOMIC ALIGNMENT SURGICAL TECHNIQUE (DSUS/JRC/0617/2179) OR THE ATTUNE ANATOMIC TIBIA BALANCED FEMUR SURGICAL TECHNIQUE (097081-180816 DSEM)? ANSWER: 1. NO. 2. NO. 3. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569651 ↗
• MalfunctionSep 2, 2021Difficult to Insert; Off-Label Use; Improper or Incorrect Procedure or Method; Difficult to Insert; Off-Label Use; Improper or Incorrect Procedure or Method

  THE SURGEON HAD TO CONTINUE TO USE THE IMPLANT AS THERE WAS NO DUPLICATE OF THAT SIZE AVAILABLE. THE SURGEON AND ASSISTANT WERE ABLE TO BEND THE POLY BACK INTO SHAPE AND CONTINUED TO USE IN THE PATIENT. SURGICAL DELAY OF 5 MINUTES. WHEN IMPACTING THE POLY INSERT ONTO THE TIBIAL TRAY, THE INSERT DEFORMED AT THE FRONT MAKING IT VERY DIFFICULT TO LOCK INTO THE TRAY. THE SURGEON WAS ABLE TO BEND AND ADJUST THE POLY BACK INTO SHAPE AND CONTINUED TO USE THIS INSERT AS THERE WERE NO OTHER OF THAT SIZE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413156 ↗
• InjuryJan 26, 2021Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POLY WAS TO THIN. THE PATIENT NEEDED TO BE TIGHTEN UP.

  Patient problems: Joint Laxity

  MAUDE report 11229658 ↗
• MalfunctionDec 2, 2020Difficult to Insert; Difficult to Insert

  SIZE ISSUE. IT WAS REPORTED THAT DURING THE SURGERY OF KNEE SURFACE REPLACEMENT, THE SIZE WAS NOT FIT TO THE TIBIAL PLATE AS THE PHOTO SHOWS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10936941 ↗
• InjurySep 14, 2020Fracture; Fracture

  (B)(6). ADVERSE EVENT DESCRIPTION: KNEE REVISION TO ADDRESS PAINFUL LEFT KNEE ARTHROPLASTY WITH MID FLEXION INSTABILITY AND RECURVATUM DEFORMITY. ADDITIONAL INFORMATION FOLLOW-UP REQUEST MEDICAL RECORDS INDICATED THE FOLLOWING WITH RESPECT TO THE PATIENT'S LEFT, NON-STUDY TOTAL KNEE ARTHROPLASTY. THE OPERATIVE RECORDS INDICATE THAT THE PATIENT HAD RECEIVED A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2016, TO ADDRESS OSTEOARTHRITIS. IT WAS NOTED THAT THE PATIENT WAS MORBIDLY OBESE, WITH A BMI OF 47. THERE WERE NO REPORTED INTRAOPERATIVE OR POST-OPERATIVE COMPLICATIONS ASSOCIATED WITH THIS PRIMARY KNEE ARTHROPLASTY. THE FOLLOWING PRODUCTS WERE IMPLANTED: J&J SIGMA CRUCIATE SUBSTITUTING SIZE 3 LEFT FEMUR COMPONENT (PRODUCT #: 196040300), J&J SIGMA MODULAR TIBIAL TRAY SIZE 2.5 COMPONENT (PRODUCT #: 158125000), J&J SIGMA ALL POLY 3 PEG SIZE 35MM OVAL DOME PATELLA COMPONENT (PRODUCT #: 960101), AND J&J SIGMA STABILIZED TIBIAL INSERT SIZE 2.5, 10MM THICK (PRODUCT #: 158122010). ON (B)(6) 2020, PATIENT'S LEFT KNEE WAS REVISED TO ADDRESS PAINFUL LEFT KNEE WITH MID-FLEXION INSTABILITY AND RECURVATUM DEFORMITY. AT THIS TIME, THE PATIENT WAS STILL MORBIDLY OBESE, AS THE PATIENT'S BMI WAS NOW 52.

  Patient problems: Adhesion(s); No Code Available; Pain

  MAUDE report 10529226 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2004 VIA TKA FOR THE PATIENT¿S LEFT KNEE JOINT. THE FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 WHICH WAS REPORTED (B)(4). IT WAS REPORTED THAT THE SECOND REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2020 BY REMOVING ALL IMPLANTS DUE TO INFECTION. THE SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10106512 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10026864 ↗
• InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS WERE REVISED TODAY, REASON FOR REVISION WAS DUE TO FAILURE OF THE PATIENTS ANATOMY.

  Patient problems: No Code Available; Pain

  MAUDE report 9616386 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNK, DOR: (B)(6) 2019 UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8889377 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DOCTOR SAID TIBIAL INSERT WAS DEFECTIVE AND TAB BENT.

  Patient problems: Not Applicable

  MAUDE report 8270198 ↗
• MalfunctionFeb 23, 2018Break; Break

  INTRAOPERATIVELY IT HAD NOT BEEN POSSIBLE TO FIX THE INLAY. THE INLAY'S LOWER BAR BROKE OFF. ANOTHER INLAY WAS AVAILABLE AND WAS INSERTED AND FIXED WITHOUT ANY ISSUES. NO SURGERY PROLONGATION, NO PART REMAINING IN PATIENT, NO ADVERSE CONSEQUENCES FOR PATIENT OR USER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291860 ↗
• InjurySep 26, 2017Malposition of Device; Malposition of Device

  IT WAS INDICATED THAT FEMORAL COMPONENT WAS IMPLANTED IN EXCESSIVE VALGUS DUE TO A CORTICAL PERFORATION WITH THE IM T-HANDLE.

  Patient problems: No Information

  MAUDE report 6893513 ↗
• InjurySep 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT. LOOSENING OCCURRED AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 6837673 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033272, K241000. One submission often covers many models, so check the product and lot details in each record.

• Z-0418-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definiti
• Z-0416-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or d
• Z-0420-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0422-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0423-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definit
• Z-0412-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0419-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive
• Z-0417-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or de
• Z-0413-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or def
• Z-0421-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-0415-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or
• Z-0414-2014 · Nov 18, 2013 · Terminated
  SIGMA LCS HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or defin
• Z-1156-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-010.
• Z-1165-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-14-015.
• Z-1179-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 2.5, 12.5 mm; Ref 1581-22-012.

…and 36 more.