P.F.C. SIGMA 1581-24-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295064411), received between Dec 3, 2017 and Mar 30, 2026 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE POLY SWAP DUE TO INFECTION. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24729925 ↗
• InjuryOct 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSERT AND PATELLA BOTH HAD POLY WEAR AND WERE REVISED. IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20343869 ↗
• MalfunctionApr 20, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON HAD DIFFICULTY PUTTING 2 PFC INSERTS INTO A PFC TRAY.

  Patient problems: Insufficient Information

  MAUDE report 16775878 ↗
• MalfunctionApr 20, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT SURGEON HAD DIFFICULTY PUTTING 2 PFC INSERTS INTO A PFC TRAY.

  Patient problems: Insufficient Information

  MAUDE report 16775862 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT SECOND STAGE REVISION TKR ON (B)(6) 2013 WHERE A PFC SYSTEM WAS UTILISED ((B)(6) HOSPITAL). - ORIGINAL INDEX SURGERY UNKNOWN, COPAL CEMENT UTILISED. PATIENT HAS PRESENTED TO DR WITH AN ACUTE INFECTION. KNEE WAS OPENED, POLY LINER REMOVED, KNEE WASHED OUT WITH PEROXIDE, CHLORHEXIDINE AND BETADINE. A NEW PFC PS INSERT WAS INSERTED. NOT OTHER DETAILS AVAILABLE. DOI: UNKNOWN. DOR (1ST): (B)(6) 2013. DOR (2ND): (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 15914410 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS DEVELOPED SOME LAXITY OVER TIME. SURGEON REMOVED INSERT AND PLACED A THICKER ONE UNEVENTFULLY, RESTORING STABILITY. THERE IS NO WEAR EVIDENT, NO MAL POSITION OR MAL ROTATION, NO INCREASED RESECTION AND NOT IMPLANTED WITH ANY PT SPECIFIC METHODOLOGY. NO PATIENT HARM OCCURRED. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15129796 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO KNEE JOINT INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. DOI: (B)(6) 2017; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13508026 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY SWAP WAS DONE. DOI: UNKNOWN. DOR: (B)(6) 2022, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13358374 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY INSTEP WAS REMOVED. DOI : UNKNOWN, DOR : (B)(6) 2022 , RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13358362 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO LABS BACK TO DETERMINE TYPE OF INFECTION. ALL IMPLANTS WERE REMOVED. DOI : (B)(6) 2018, DOR : (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13205655 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR PATELLA RESURFACING. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. FACILITY NAME OF ORIGINAL IMPLANT: HUG. WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: PAIN. REASON FOR REVISION SURGERY. PAIN.

  Patient problems: Pain

  MAUDE report 13011373 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. THERE WAS NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: (B)(6) 2018, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12860880 ↗
• MalfunctionMar 30, 2020Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT ON (B)(6) 2019, A PRODUCT WITH AN EXPIRATION DATE OF (B)(6) 2019 WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9900776 ↗
• InjuryNov 7, 2019Naturally Worn; Naturally Worn

  REASON FOR REVISION WAS TIBIAL LOOSENING APPEARED TO BE APPARENT ON XRAY AND BONE SCANS (AS PER SURGEON). IMPLANTS REMOVED. CEMENT FRAGMENTS AMD OLD BLOOD FOUND WITHIN THE JOINT SPACE. SAMPLES OF SYNOVIUM TAKEN. IMPINGEMENT APPARENT ON THR POSTERIOR OF THE POLY INSERT POST AND ON THE POSTERIOR POLY INSERT ARTICULATING SURFACE. THERE ARE NO IMAGES OR X RAYS AVAILABLE. SURGEON PROVIDED NO SPECIFIC CAUSE FOR REVISION BY THE END IF THE CASE.

  Patient problems: No Code Available

  MAUDE report 9291689 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION DUE TO JOINT PROSTHESIS. DEPUY CEMENT WAS USED. NO EXTENDED TIME. PRODUCT NOT AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8436677 ↗
• InjurySep 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2017 DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 7903772 ↗
• MalfunctionFeb 22, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  TIBIAL INSERT REF: (B)(4). SIZE 4X10MM REFUSED TO ¿SIT IN PLACE¿ AFTER SEVERAL ATTEMPTS BY A VERY COMPETENT CONSULTANT ORTHOPAEDIC SURGEON. DELAY IN SURGERY APPROXIMATELY 15 MINS, NEW IMPLANT OPENED AND INSERTED WITHOUT ANY ISSUES. NO POTENTIAL PATIENT COMPLAINT. REPORTING HOSPITAL REQUEST INSPECTION OF THE CONTAMINATED IMPLANT AND A REPLACEMENT THERE OF.

  Patient problems: Not Applicable

  MAUDE report 7288405 ↗
• InjuryDec 3, 2017Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS POLY AND PATELLA WEAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7078218 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-1190-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA stabilized insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-25-010.
• Z-1159-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-13-010.
• Z-1170-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 15 mm; Ref 1581-15-015.

…and 36 more.