P.F.C. SIGMA 96-2731Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295244066), received between Jun 9, 2020 and Apr 28, 2022 — classified as 2 injuries.

29 other recalls cover devices cleared under the same FDA submission (K241000, K950010, K952830, K963117, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY DUE TO RESTRICTED RANGE OF MOTION STATUS POST TKA. THE KNEE WAS DEBRIDED AND A THINNER INSERT WAS PLACED WITH IMPROVED RANGE OF MOTION. NO INFECTION, DELAYS OR BROKEN INSTRUMENTS REPORTED. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 14244086 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A POLY EXCHANGE WHILE DOING A MANIPULATION OF THE KNEE. NO ADDITIONAL INFORMATION AVAILABLE. DOI: (B)(6) 2019. DOR: (B)(6) 2020. RIGHT KNEE.

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

  MAUDE report 10135377 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K950010, K952830, K963117, 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-0424-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2731.
• Z-0401-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
• 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-0426-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 17.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-2733.
• 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.
• Z-0423-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 10 mm, 3, UHMWPE, sterile; Product Code/REF 96-2730.
• Z-0420-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652.
• Z-0418-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643.
• 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-0421-2008 · 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, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712.
• 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-0400-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
• Z-0427-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 71 mm M/L, 47 mm A/P, 25 mm, 3, UHMWPE, sterile; Product Code/REF 96-2736.
• 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.

…and 14 more.