P.F.C. 86-0127Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295215486), received between Oct 31, 2018 and Apr 30, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).

24 other recalls cover devices cleared under the same FDA submission (K241000, K884796, K952830); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE REPORTER HAD A LOOSE TIBIA NEEDED TO PULL IT OUT PUT A LONG STEM PLUS AUGMENTS. DOI-UNKNOWN DOR-(B)(6) 2026 AFFECTED SIDE-LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25048457 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT RECEIVED A SECOND LEFT KNEE REVISION TO ADDRESS PAIN, INSTABILITY, REMOVAL OF FIBROUS TISSUE, AND PATELLAR TENDON REPAIR. ALL PRODUCTS WERE REVISED WITH THE EXCEPTION OF THE PATELLAR COMPONENT, WHICH WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR FEMORAL COMPONENT AND UNIVERSAL SLEEVE, DEPUY TIBIAL TRAY, STEM, AND INSERT, AND DEPUY CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2017 (PATELLA), DOI: (B)(6) 2018 (COMPETITOR CEMENT, INSERT, TIBIA AND FEMUR - CAPTURED IN (B)(4)), DOR2: (B)(6) 2019, LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 12010312 ↗
• InjuryOct 31, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 8024003 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K884796, K952830. 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-3099-2011 · Jun 28, 2011 · Terminated
  PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacryla
• 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-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-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-0397-2008 · Sep 27, 2007 · Terminated
  Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
• 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-1345-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4623.
• Z-1344-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4624.
• Z-1333-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144.
• Z-1332-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031.
• Z-1341-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 6, 15.0 mm; Ref 98-4198.
• Z-1343-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4618.
• Z-1342-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-4610.

…and 9 more.