LCS COMPLETE POROCOAT 1294-04-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295021797), received between Mar 28, 2018 and Nov 16, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryNov 16, 2021Osseointegration Problem; Osseointegration Problem

  REVISION KNEE SURGERY FOR ASEPTIC LOOSENING OF FEMORAL, TIBIAL AND PATELLA IMPLANTS OF THE LEFT KNEE. BONE SCANS HIGHLIGHTED "HOT" ON THE ABOVE THREE COMPONENTS. THE IMPLANTS WERE EXPLANTED AND REPLACED WITH AN ATTUNE REVISION KNEE SYSTEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12820078 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT TKR ON (B)(6) 2016 WHERE AN UNCEMENTED LCS FEMORAL COMPONENT AND AN UNCEMENTED LCS TIBIAL COMPONENT WERE UTILIZED PATIENT HAS REPORTED THAT THE KNEE HAS NEVER FELT RIGHT AND HAS HAD ONGOING LOW LEVELS OF DISCOMFORT. PATIENT HAS PRESENTED TO THE GOLD COAST UNIVERSITY HOSPITAL FOLLOWING A BUMP TO THE KNEE WITH SUBSEQUENT PAIN AND SWELLING. THE KNEE APPEARED TO BE INFECTED. A WASHOUT WAS PERFORMED (DATE AND SURGEON UNKNOWN) AND SAMPLES TAKEN. STAPH WAS GROWN/ CULTIVATED. DOI: (B)(6) 2016, DOE: UNKNOWN, LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Swelling/ Edema

  MAUDE report 12067740 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12051376 ↗
• InjuryMar 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY: (B)(6) 2014. THIS IS PATIENT'S 1ST REVISION FOR STIFFNESS AND PAIN.

  Patient problems: Not Applicable; Pain

  MAUDE report 7378222 ↗