P.F.C. SIGMA 86-4180Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295216421), received between Jul 20, 2018 and Apr 23, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).

7 other recalls cover devices cleared under the same FDA submission (K830927, K961685); 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: LOOSE (UNKNOWN COMPONENTS OR INTERFACE). AT REVISION TIBIAL INSERT SHOWED MINOR YELLOWING AND SEVERAL POLY LOSS.

  Patient problems: Insufficient Information

  MAUDE report 19166005 ↗
• InjuryAug 29, 2022Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PRIMARY PFC FB OPERATION APPROX 15 YEARS AGO. TIBIA NEEDED REVISING. CR FEMUR REMAINS INSITU - TIBIA REMOVED AND MBT TRAY WITH SLEEVE AND STEM INSERTED DOI: JAN 2007. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15312021 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED LEFT TOTAL KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9504387 ↗
• InjuryOct 28, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE AFFECTED SIDE IS THE RIGHT KNEE. REMOVED SIGMA PLI GVF INS 2 8MM, PFC*SIGMA/OV DOME PAT 3 PEG,32, DEPUY CMW 1G 40G AND PFC*SIGMA C/R NPOR FEM RT SZ 2 FROM D11 FIELD.

  Patient problems: No Code Available

  MAUDE report 9247172 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. COMPETITOR CEMENT WAS USED. IT WAS ALSO REPORTED THAT IT WAS A (B)(6). COMPONENTS WERE REMOVED AND ANTIBIOTIC ARTICULATING SPACER WAS IMPLANTED. ONLY CATALOG AND LOT NUMBER ON TIBIA COMPONENT AVAILABLE. FEMUR WAS A 2RIGHT CR CEMENTED. 2X10 XLK CR FB INSERT. DOI: (B)(6) 2015, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8707746 ↗
• InjuryMay 15, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 VIA TKA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, BY REPLACING THE TRAY (P/N: 864180) AND THE INSERT (P/N: 960420) WITH A SLEEVE (P/N: UNKNOWN) OF M.B.T. REVISION SYSTEM DUE TO A LOOSENING ON TIBIAL SIDE. THE TIBIAL SIDE HAD TILTED IN MEDIAL DIRECTION. NO LOOSENING WAS OBSERVED ON FEMORAL SIDE AND THERE WAS NO INFECTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 8611688 ↗
• InjuryAug 15, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO LOOSENING OF TIBIAL AND FEMORAL COMPONENTS AND OSTEOLYSIS. DOI: (B)(6) 2000. DOR: (B)(6) 2018. (LEFT KNEE).

  Patient problems: Not Applicable; Osteolysis; Pain

  MAUDE report 7784071 ↗
• InjuryJul 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PRIMARY SURGERY WAS PERFORMED TO IMPLANT THE IMPLANTS TO THE PATIENT¿S LEFT KNEE JOINT (DATE OF PRIMARY SURGERY WAS UNKNOWN). THE PATIENT COMPLAINED THE PAIN (ABOUT A YEAR AGO), SO THAT THE SURGEON FOUND THE LOOSENING OF THE KNEE IMPLANTS. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 DUE TO THE LOOSENING. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: Not Applicable; Pain

  MAUDE report 7706427 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K830927, K961685. One submission often covers many models, so check the product and lot details in each record.

• Z-0057-2007 · Sep 14, 2006 · Terminated
  Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
• Z-1319-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
• Z-1318-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
• Z-1317-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
• Z-1315-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
• Z-1320-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
• Z-1316-05 · May 26, 2005 · Terminated
  Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.