P.F.C. 86-0123Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295215448), received between Jul 25, 2018 and Jun 14, 2024 — classified as 7 injuries, 2 malfunctions.

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

17 other recalls cover devices cleared under the same FDA submission (K241000, K884796, K923807); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2024Migration; Migration

  IT WAS REPORTED THAT THE TIBIA PLATEAU HAD COLLAPSED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19538775 ↗
• InjuryDec 20, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  MEDICAL RECORDS RECEIVED: THE INDICATIONS FOR SURGERY INCLUDED PAIN AND SWELLING.

  Patient problems: Adhesion(s); Insufficient Information; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 18363943 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE CLEANING AND RE-REVISION SURGERY AFTER THE CONFIRMATION OF INFECTION. THIS PC REPORTS THE PAIN AND INFECTION AFTER THE REVISION SURGERY. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED. IT IS ALSO UNKNOWN WHETHER THE IMPLANTS USED IN THE PRIMARY SURGERY ARE JJ PRODUCTS OR NOT. ON (B)(6) 2022, THE REVISION SURGERY WAS PERFORMED WITH THE IMPLANTS IN QUESTION. THE REASON FOR THE REVISION IS UNKNOWN. AFTER THE REVISION SURGERY, ON (B)(6) 2023, THE PATIENT CAME TO THE HOSPITAL COMPLAINING OF THE SUDDEN KNEE PAIN, AND THE INFECTION WAS CONFIRMED. NO FURTHER INFORMATION IS AVAILABLE. DOI; (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17116880 ↗
• MalfunctionOct 27, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE UNIVERSAL STEM COULD NOT BE MOUNTED AND FIXED INTO THE TIBIA. SINCE COMPLETE ASSEMBLY WAS NOT POSSIBLE, THE TIBIA CONSTRUCT WITH WEDGES COULD NOT BE IMPLANTED. THE PROCEDURE COMPLETED WITH NEW IMPLANTS, NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685304 ↗
• MalfunctionMar 29, 2022Difficult to Insert; Difficult to Insert

  COMPONENTS WOULD NOT ATTACH TO ONE ANOTHER. THE INSTRUMENTS DISCONNECTED WHEN THE SURGEON PULLED ON THEM INSTEAD OF UNSCREWING THEM. THREADING MAY BE DAMAGED. SURGICAL DELAY OF 10 MINUTES OCCURRED. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 13935102 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9466529 ↗
• InjurySep 13, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  ON (B)(6) 2018, THE PATIENT UNDERWENT A THIRD RIGHT KNEE REVISION DUE TO PAIN, ARTHROFIBROSIS, DISCOMFORT, DECREASED RANGE OF MOTION, SCARRING, AND TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED A TIBIAL STRESS FRACTURE WHILE REMOVING THE TIBIAL TRAY. THE FRACTURE WAS CORRECTED WITH A SCREW AND CEMENT. TWO DEPUY CEMENT WERE USED DURING THE FIRST REVISION ON (B)(6) 2016. DOI: (B)(6) 2016, ( 2 DEPUY CEMENTS ); (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Discomfort; Fibrosis; Loss of Range of Motion; No Code Available; Pain; Scarring

  MAUDE report 9036548 ↗
• InjuryMar 5, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8391044 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TKR; DR (B)(6) - (B)(6) HOSPITAL (B)(6) 2018 - PATIENT UNDERWENT PRIMARY TOTAL KNEE REPLACEMENT ; PRIMARY DATE TO BE CONFIRMED, WHERE A PFC PS FIXED IMPLANT WAS UTILIZED (DR (B)(6)). PATIENT HAS REPORTED THAT SINCE THE PRIMARY SURGERY SHE HAS BEEN VERY UNHAPPY WITH HER KNEE, EXPERIENCING BOTH PAIN AND INSTABILITY FROM DAY 1. PREVIOUS SURGICAL NOTES HAVE NOT BEEN MADE AVAILABLE BUT X RAYS INDICATED SOME FORM OF ISSUE WITH THE EXTENSOR MECHANISM; WITH PATELLA ALTO AND ANCHORS VISIBLE ON X RAY (INDICATING POSSIBLE PATELLA TENDON PULL OFF OR RUPTURE. ON OPENING THE KNEE (DR (B)(6), (B)(6), (B)(6) 2018) THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE WELL FIXED. THE KNEE WAS UNSTABLE THROUGH A RANGE OF MOTION WITH IMBALANCED GAPS THROUGH BOTH EXTENSION AND FLEXION. COMPONENTS WERE REMOVED AND AN ATTUNE REVISION IMPLANT UTILISED. FEMORAL COMPONENT WAS EXTERNALLY ROTATED BY APPROX 8 DEGREES TO BALANCE THE FLEXION GAP. KNEE WAS STABLE THROUGH THE RANGE. PATELLA COMPONENT WAS REVISED AND THE PATELLA TENDON REPAIRED UTILISING A LARS LIGAMENT. FEMALE PATIENT INITIALS (B)(6), AGED (B)(6), DOB: (B)(6). DISCARDED UNKNOWN JRN: 1 X PFC PS FEMORAL COMPONENT . DISCARDED UNKNOWN JRN: 1 X

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 7719243 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241000, K884796, K923807. 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-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-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-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-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-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-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-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-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-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-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-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-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.

…and 2 more.