P.F.C. SIGMA 1581-23-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295064251), received between Jul 20, 2017 and Jun 26, 2025 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A BILATERAL KNEE I&D. BOTH POLYS WERE SWAPPED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22335765 ↗
• MalfunctionDec 12, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. WHEN IMPACTED BY THE SURGEON, THE INSERT WOULD NOT SEAT PROPERLY ON THE TIBIAL TRAY IMPLANT. ANOTHER IMPLANT WAS OPENED AND IMPACTED ON THE TIBIAL TRAY AND SEATED NORMALLY WITHOUT ANY ISSUE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913697 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. NO DELAYS.

  Patient problems: Unspecified Infection

  MAUDE report 18867257 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2018. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17508961 ↗
• InjuryJul 19, 2023Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO POLY WEAR. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17350950 ↗
• MalfunctionMay 22, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT PRODUCT WAS IMPLANTED WITH AN EXPIRATION DATE THE MAY 31, 2022.

  Patient problems: Insufficient Information

  MAUDE report 16974459 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. THE ORIGINAL IMPLANT DATE WAS UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16590756 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A PAINFUL LEFT TOTAL KNEE. PREVIOUS SURGERY DATE AND LOCATION WERE UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16278606 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15894385 ↗
• InjuryFeb 21, 2022Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  TKR COMPLETED 18 YEARS AGO. REVISION COMPLETED DUE TO PATIENT COMPLAINTS. SHE HAD NO PAIN BUT COMPLAINED OF A ¿SQUISHY¿ SENSATION. POLY INSERT DISASSOCIATED FROM THE TIBIAL TRAY AND WAS SHOWING SOME SIGNS OF WEAR. POLY AND TIBIAL INSERT WERE EXCHANGED.

  Patient problems: Insufficient Information

  MAUDE report 13569851 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. THE LINER WAS EXCHANGE. NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10868356 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2016, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10483195 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LATE INFECTION. WASH OUT AND POLY EXCHANGE PERFORMED. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10401397 ↗
• InjuryAug 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. PREVIOUS SURGICAL DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8889119 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PATELLA AT THE BONE TO CEMENT INTERFACE. PATELLA FELL OFF THE BONE. SURGEON REMOVED LOOSE COMPONENT AND ALSO DID A TIBIAL POLY SWAP. APPEARED TO BE OSTEOLYSIS OF THE PATELLA AND DID NOT RESURFACE THE PATELLA. NO FALLS OR TRAUMA. DOI: (B)(6) 2007; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8780581 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8235531 ↗
• InjuryDec 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  UNABLE TO GET THE LOCKING TABS TO ENGAGE WITH THE TIBIAL TRAY AND GET CORRECT FIXATION OF THE INSERT.

  Patient problems: Not Applicable

  MAUDE report 8164188 ↗
• MalfunctionSep 12, 2018Expiration Date Error; Expiration Date Error

  OUR CUSTOMER SERVICE TEAM INDICATED DURING PRODUCT INVOICING THAT PHYSICIAN IMPLANTED PRODUCT AFTER EXPIRE DATE. NO INFORMATION FROM CUSTOMER AVAILABLE. NO CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7869562 ↗
• InjuryJan 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS SWELLING AND INFECTION. POLY SWAP AND WASHOUT.DOI: (B)(6) 2017, DOR: (B)(6) 2017, LEFT KNEE.

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 7205240 ↗
• InjuryAug 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 6833950 ↗
• MalfunctionJul 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE SURGEON COULDN'T GET INSERT TO LOCK IN. PRODUCT COMPLAINT FOR IMPLANT.

  Patient problems: No Information

  MAUDE report 6728798 ↗

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-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-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-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-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-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-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-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-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-1166-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-14-017.
• Z-1163-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008.

…and 36 more.