P.F.C. 98-4159Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295252498), received between Mar 17, 2020 and Mar 17, 2020 — classified as 1 injury.

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

16 other recalls cover devices cleared under the same FDA submission (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2020Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS OSTEOLYSIS AND POLYETHYLENE WEAR. DATE OF IMPLANTATION: (B)(6) 1995. DATE OF REVISION #1: (B)(6) 2010 (INSERT). DATE OF REVISION #2: (B)(6) 2020. (LEFT KNEE). TREATMENT: FEMUR, TIBIAL TRAY, TIBIAL INSERT WERE REVISED TO REVISION COMPONENTS.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9842434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-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-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-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-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-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.
• 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-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-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-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-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-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.

…and 1 more.