P.F.C. SIGMA 1581-22-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295064084), received between Sep 12, 2017 and Oct 23, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT I&D OF RIGHT KNEE AND POLY SWAP WAS DONE. AFFECTED SIDE: RIGHT KNEE

  Patient problems: Insufficient Information

  MAUDE report 23366261 ↗
• MalfunctionMar 6, 2025Difficult to Insert; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Receipt by User; Device Damaged Prior to Use

  IT WAS REPORTED THAT WHEN INSTALLING THE POLYETHYLENE, IT WAS NOTICED THAT THE FITTING WAS DAMAGED/BENT UPWARDS, WHICH MADE IT IMPOSSIBLE TO CORRECTLY PLACE THE POLYETHYLENE ON THE TIBIA. A NEW POLYETHYLENE WAS OPENED TO PROCEED WITH THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541030 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2023, A REVISION SURGERY WAS PERFORMED DUE TO THE SUSPECTED INFECTION. THE SAID IMPLANTS WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2014. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17650283 ↗
• MalfunctionJul 12, 2023Difficult to Insert; Difficult to Insert

  DEVICE REPORT FROM DEPUY SYNTHES MALAYSIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT ON (B)(6) 2023, THE INSERT WOULD NOT LOCK TO THE TIBIAL TRAY. A GAP WAS FOUND BETWEEN INSERT AND TIBIAL TRAY AND A 10MM INSERT WAS IMPLANTED INSTEAD. THERE WAS A SURGICAL DELAY OF AN UNKNOWN TIME. THIS REPORT IS FOR A SIGMA STAB GVF INS 2.5 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 17313329 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT OF MINE HAD A LEFT KNEE REPLACEMENT ( OP NOTE ENCLOSED). A 2.5 SIZED CRUCIATE SACRIFICING TKR WAS PERFORMED. HER POST OP RANGE ON THE TABLE WAS 3 - 120 DEGREES. (ON THE RIGHT SIDE A SIZE 3 WAS INSERTED). A FEW MONTHS LATER THE RANGE OF MOVEMENT IN THE LEFT KNEE REDUCED AND IN OCTOBER 2021 WAS 30 - 75 DEGREES. THE KNEE WAS REVISED AT ANOTHER HOSPITAL. PATIENT HAS COMPLAINED TO ME: THAT I HAVE USED TOO BIG A PROSTHESIS. THE IMPLANT IS TOO DISTAL.

  Patient problems: Loss of Range of Motion

  MAUDE report 16992299 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. POLY EXCHANGE AND WASHOUT COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 16096141 ↗
• MalfunctionJul 20, 2022Difficult to Insert; Difficult to Insert

  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 15065654 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2011. DOR: (B)(6) 2020. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10874538 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED LEFT KNEE. REMOVAL DATE (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10259468 ↗
• InjuryMar 26, 2020Fracture; Difficult to Insert; Off-Label Use; Fracture; Difficult to Insert; Off-Label Use

  DURING TOTAL KNEE REPLACEMENT PFC PS, WHEN IMPLANTING THE INSERT 8MM, FIND DIFFICULTY TO FIX THE INSERT TO THE TIBIAL TRAY. FORCE WAS USED TO PUSH THE INSERT IN BUT STILL CANNOT BE FIXED. INSERT WAS REMOVED TO HAVE A CLOSER LOOK, FOUND THAT THE POSTERIOR BUMP (LOCK TO THE POSTERIOR TIBIAL TRAY) ON ONE OF THE SIDE WAS CHIPPED OFF. AS THERE IS NO EXTRA IMPLANT AVAILABLE, THE SURGEON TRIED TO PUT THE TRIAL SZ10MM BUT UNABLE TO. SHE DECIDED TO USE THE 8MM WHICH HAD THE CHIPPED PART AT THE POSTERIOR TO IMPLANT INTO PATIENT. THE SURGERY WAS DELAYED 10 MINUTES AND THERE WERE NO REPORTED PATIENT HARMS.

  Patient problems: No Code Available

  MAUDE report 9883194 ↗
• MalfunctionJun 19, 2019Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2019, THE INSERT (P/N: 158122008) DIDN¿T FIT WITH AN UNKNOWN TIBIAL TRAY (P/N: UNKNOWN). ANOTHER INSERT WHICH WAS PREPARED FOR THE OPPOSITE SIDE WAS USED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8714662 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT I AND D. IT WAS ALSO STATED THAT THERE WAS POLY EXCHANGE WHILE IRRIGATING.

  Patient problems: Unspecified Infection

  MAUDE report 6859027 ↗

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-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-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-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-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-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-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-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-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-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-1169-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 1581-15-012.
• 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-1157-05 · May 26, 2005 · Terminated
  Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12-017.

…and 36 more.