P.F.C. 86-0124Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295215455), received between Sep 20, 2018 and Aug 11, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

16 other recalls cover devices cleared under the same FDA submission (K241000, K884796); 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.

• InjuryAug 11, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Migration; Fracture; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Migration

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES FRACTURE BETWEEN TIBIAL STEM AND TIBIAL BASEPLATE RESULTING TO PAIN AND INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: Adhesion(s); Inadequate Osseointegration; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 15209111 ↗
• InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  KNEE REVISION FOR TIBIAL AND FEMORAL LOOSENING, KNEE PAIN AND STIFFNESS OF THE KNEE. LOOSENING AT THE CEMENT/BONE INTERFACE WITH CEMENT NOT FROM DEPUY. SURGICAL TIME WAS NOT EXTENDED. TKA IMPLANTED IN 2008.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 12203801 ↗
• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT MANUFACTURER WAS USED. DOI: (B)(6) 2018 (FEMUR ONLY). DOI: (B)(6) 2018. DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9218691 ↗
• InjurySep 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND TIBIAL TRAY AND FEMORAL COMPONENT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED IN THE PREVIOUS OPERATION. DOI: (B)(6) 2005 (STEM). DOI: (B)(6) 2007 (FEMORAL). DOR: (B)(6) 2009.

  Patient problems: Not Applicable; Pain

  MAUDE report 7895189 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K884796. One submission often covers many models, so check the product and lot details in each record.

• 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-1334-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 10.0 mm; Ref 98-4143.
• 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-1346-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 15.0 mm; Ref 98-4626.
• 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-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-1336-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152.
• Z-1335-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-4142.
• Z-1340-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4157.
• 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.
• Z-1338-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4154.
• Z-1339-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4158.
• 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-1337-05 · May 26, 2005 · Terminated
  Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 3, 17.5 mm; Ref 98-4151.

…and 1 more.