P.F.C. SIGMA 1581-15-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295063568), received between Mar 7, 2018 and Jul 17, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).

12 other recalls cover devices cleared under the same FDA submission (K032151, 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22531627 ↗
• InjuryAug 11, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2018, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10393201 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED HER PRIMARY TKR ON THE (B)(6) 2012. PATIENT REVISED FOR INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 9672189 ↗
• InjuryJul 12, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2015. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8784608 ↗
• InjuryFeb 7, 2019Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

  IT WAS REPORTED THE IMPLANTS WERE REMOVED DURING KNEE REVISION SURGERY ON (B)(6) 2019 DUE TO TIBIAL LOOSENING AND POSSIBLE TIBIAL IMPLANT POSITIONING (VARUS). THE ORIGINAL SURGERY OCCURRED IN 2011.

  Patient problems: No Code Available

  MAUDE report 8315628 ↗
• MalfunctionJan 24, 2019Fitting Problem; Fitting Problem

  THE 1.5 COBALT CHROME FIXED BEARING TRAY WOULD NOT ACCEPT A 30MM CEMENTED STEM EXTENSION. WOULD NOT FULLY SEAT AS IF THERE WAS SOME SORT OF BURR OR PERHAPS THE TIBIAL TRAY WAS IMPROPERLY TAPPED AND THREADED.

  Patient problems: Not Applicable

  MAUDE report 8273871 ↗
• MalfunctionJun 26, 2018Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  EMAIL STATES THAT THE 1.5 COCR TRAY IS NOT FIXING PROPERLY WITH 14*115 FLUTED ROD. TIP OF STEM IS NOT GOING IN WITH BOTTOM OF THE TIBIAL TRAY. IT WAS VERY TIGHT AND MAL THREATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7638504 ↗
• MalfunctionApr 12, 2018Defective Component; Defective Component

  FAILURE TO PROPERLY SEAT 30MM STEM EXTENSION IMPLANT TO SIGMA FIXED BEARING TIBIAL TRAY. SURGICAL TECH COULD NOT FULLY SEAT THREADED STEM EXTENSION IMPLANT TO TIBIAL TRAY CONE EVEN WHEN APPLYING SIGNIFICANT MECHANICAL TORQUE FORCE. UNDER NORMAL CIRCUMSTANCES THE STEM EXTENSION IMPLANT CAN BE MOSTLY SEATED TO THE TIBIAL IMPLANT BY HAND RESULTING IN THE NEED ONLY TO SLIGHTLY TORQUE TO APPROPRIATE TENSION USING THE STEM WRENCH INSTRUMENT. IN THIS CASE THE TECH WAS NOT ABLE TO FULLY SEAT WITH SIGNIFICANT EFFORT. SURGEON THEN REQUESTED TO HAVE ANOTHER (ADDITIONAL SAME SIZED STEM IMPLANT) OPENED WITH A SIMILAR END RESULT. HE THEN ATTEMPTED TO FURTHER TORQUE UNDER HIS OWN STRENGTH AND WAS FINALLY ABLE TO SEAT THE STEM TO A POINT APPEARING TO BE FLUSH WITH THE THREADED TIBIAL CONE IMPLANT. THE CONSENSUS WAS THAT PERHAPS THERE WAS A DEFECT IN THE THREAD PATTERN OF THE RECEIVING TIBIAL TRAY IMPLANT AND THAT THROUGH SIGNIFICANT TORQUE FORCE THE HARDER TIBIAL TRAY THREADS PERHAPS CROSS THREADED THE SOFTER METAL STEM THREADS RESULTING IN FULL OR NEARLY FULL SEATING OF THE TWO PIECES. BOTH OPENED STEM EXTENSION IMPLANTS WERE SUBSEQUENTLY WASTED DUE TO CIRCUMSTANCES UNRELATED TO THE DIFFICULTY OF

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7424626 ↗
• InjuryMar 7, 2018Break; Loose or Intermittent Connection; Break; Loose or Intermittent Connection

  ASEPTIC LOOSENING OF A TIBIA IMPLANTED IN 2016, ON REMOVAL ON THE TRAY THE PLASTIC SCREW AT THE BOTTOM OF THE TIBIA WAS CRACKED IN MULTIPLE PLACES. MR (B)(6) HAS NEVER SEEN THIS BEFORE AND WONDERS IF THIS MAY HAVE A RELATION TO THE LOOSENING OF THE TIBIAL TRAY AND ALSO HAS WONDERED WHAT HAS CAUSED THIS TO CRACK INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7321045 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032151, 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-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-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-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-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-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-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-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-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-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