P.F.C. 86-6404Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295216926), received between Mar 27, 2020 and Mar 21, 2023 — classified as 6 injuries.

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

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AND STERLING AND WAS TESTED FOR NICKEL ALLERGY. THE TEST CAME BACK POSITIVE SO THE SURGEON TOOK IT ALL OUT AND PUT IN AN AESCULAP REVISION CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 16584905 ↗
• InjuryFeb 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN I&D WITH A REVISION OF THE LEFT KNEE LPS HINGED INSERT TO TREAT PAIN AND SWELLING SECONDARY TO (B)(6) INFECTION. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015, DOR: (B)(6) 2016, (LEFT KNEE).

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13567743 ↗
• InjuryFeb 17, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  AMPUTATION. THE PATIENT RECEIVED AN ABOVE THE KNEE AMPUTATION DUE TO SIGNIFICANT PAIN, INFECTION, SWELLING, DRAINING, LYMPHEDEMA AND INABILITY TO AMBULATE. UPON ENTERING THE JOINT, THE CONSTRUCT WAS NOTED TO BE GROSSLY LOOSE AND INFECTED. THE AMPUTATION WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2017; DOR: (B)(6) 2021; UNKNOWN KNEE . THIS COMPLAINT IS ALSO LINKED TO (B)(4) WHERE THE TIBIAL TRIAL WAS REPORTED. ANOTHER PC IS LINKED TO THIS COMPLAINT UNDER (B)(4) WHERE THE EVENT HAPPENED IN BETWEEN APR 2017 ¿ MAR 2019.

  Patient problems: Ambulation or Postural Difficulties; Fluid Discharge; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 13549622 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AMPUTATION WAS DONE. DOI - (B)(6) 2015; DOR - (B)(6) 2016; UNKNOWN KNEE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 13549339 ↗
• InjuryMar 29, 2021Loss of or Failure to Bond; Fracture; Loss of or Failure to Bond; Fracture

  SURGEON REPORTED TO BFARM: "THE KNEE ENDOPROSTHESIS WAS IMPLANTED IN 2002. SINCE 2013, LOOSENING OF THE PROSTHESIS AND FRACTURE OF THE TIBIAL STEM IS KNOWN. DUE TO MULTIPLE INTERNAL DISEASES, THE PATIENT WAS NOT ABLE TO UNDERGO SURGERY UP TO NOW. NOW, KNEE-TEP REMOVAL WAS PERFORMED BECAUSE OF KNEE-TEP LOOSENING AND STEM-FRACTURE."

  Patient problems: Insufficient Information

  MAUDE report 11584827 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. SURGEON REMOVED EVERYTHING. DOI: (B)(6) 2019, (B)(6) 2019 (INSERT). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9891432 ↗