P.F.C. SIGMA 96-0052Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295232346), received between Sep 11, 2020 and Mar 12, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

24 other recalls cover devices cleared under the same FDA submission (K241000, K950010, K952830, K971189); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A TKA. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, A SUPRACONDYLAR FRACTURE OCCURRED. THE CAUSE IS NOT RELATED TO THE IMPLANTS. THE NAIL WILL BE REPLACED ON (B)(6) 2025. IF THE INSERT IS IN THE WAY DURING REVISION SURGERY, THE SURGEON PLANS TO REPLACE IT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21584772 ↗
• MalfunctionNov 21, 2022Device Damaged Prior to Use; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Device Damaged Prior to Use; Device-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE AFFECTED SIDE? LEFT, OR RIGHT? RIGHT SIDE. B. PLEASE CONFIRMED IF BOTH THE IMPACTOR OR THE FEMORAL COMPONENT CONTRIBUTED TO THE DEVICE INTERACTION ISSUE: AFTER HAD KNOWLEDGE OF THIS SITUATION I SPOKE WITH THE SURGEON IN CHARGE TO UNDERSTAND ALL THE DETAILS ABOUT THE ISSUE AND HE EXPLAINED TO ME THAT WHEN THEY ATTACHED THE FEMORAL COMPONENT TO THE IMPACTOR, AFTER TIGHTENING, THE IMPLANT FELT ON THE FLOOR. HE SUSPECTED A DEFECT IN THE FEMORAL. AFTER OPENING ANOTHER ONE, EVERYTHING WENT WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833433 ↗
• InjuryJan 29, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED STATED THAT IT WAS REPORTED THAT THE REVISION SURGERY WHICH WAS SCHEDULED ON (B)(6) 2021 VIA TKA FOR THE PATIENT¿S RIGHT KNEE JOINT WAS PERFORMED ON SCHEDULE. THE PATIENT HAD BOTH HIP JOINTS REPLACED WITH ARTIFICIAL JOINTS, AND HAD UNDERGONE A REVISION SURGERY FOR LEFT HIP JOINT LAST YEAR. AFTER THAT, SHE VISITED THE HOSPITAL DUE TO PAIN WHICH WAS CAUSED BY A POSSIBLE BIAS OF THE LOAD TO THE RIGHT SIDE. THE FEMUR WAS DIGGING UPWARD, AND IT WAS SEEMED THAT THE LOOSENING ALSO OCCURRED IN TIBIA SIDE. THE SURGEON REPLACED ALL IMPLANTS WITH ATTUNE REVISION SERIES IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 11254764 ↗
• InjurySep 11, 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. IT WAS REPORTED THAT THE PATIENT TOLD SOMETHING UNUSUAL TO THE SURGEON WHEN FOLLOW-UP IN (B)(6) 2020. THE SURGEON CONFIRMED SPIN-OUT BY X-RAY. AN ABNORMAL SOUND WAS HEARD WHEN BEND AND STRETCH, AND THE PATIENT COULD NOT BEND AND STRETCH SMOOTHLY. THE PATIENT ALSO HAD SUBLUXATION AT ANKLE JOINT. THE PATIENT RESTS WITH SPIN-OUT NOW. THE SURGEON THOUGHT THAT THE SPIN-OUT WAS NOT CAUSED BY THE IMPLANTS AT THIS STAGE, THE REASON OF SPIN-OUT WAS UNKNOWN. HE PLANNED TO REPLACE THE TIBIAL INSERT FOR FIRST-LINE CHOICE, OR TO REPLACE THE TIBIAL INSERT AND THE TIBIAL TRAY FOR SECOND-LINE CHOICE SINCE HE PLANNED TO USE A FB TIBIAL INSERT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10521926 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K950010, K952830, K971189. One submission often covers many models, so check the product and lot details in each record.

• Z-2949-2018 · Jul 18, 2018 · Terminated
  P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
• Z-0394-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453.
• Z-0386-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431.
• Z-0391-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442.
• Z-0422-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713.
• Z-0389-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440.
• Z-0393-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452.
• Z-0398-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
• Z-0396-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
• Z-0388-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433.
• Z-0399-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
• Z-0385-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430.
• Z-0390-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441.
• Z-0392-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451.
• Z-0387-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432.

…and 9 more.