LCS COMPLETE POROCOAT 1294-03-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295021681), received between Apr 20, 2018 and Apr 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2022Fracture; Fracture

  RUPTURE OF THE FEMORAL COMPONENT WITH FEMORAL BONE EROSION AND FRACTURE OF THE MEDIAL AND LATERAL CORTEX. REVISION SURGERY NECESSARY. SURGEON REFERS THAT THE PATIENT HAD SEVERE HYPOKINETIC SYNDROME DUE TO PROGRESSIVE INABILITY TO WALK.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Pocket Erosion

  MAUDE report 14137126 ↗
• InjuryApr 20, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN, POOR FUNCTION AND FEMORAL LOOSENING AT THE BONE TO IMPLANT INTERFACE. IT WAS ALSO REPORTED THAT WHEN THEY OPENED THE PATIENT AND STARTED THE STABILITY OF THE FEMORAL COMPONENT IT WAS FOUND TO BE NOT WELL FIXED. THE FEMUR WAS REMOVED AND STEMMED SIGMA PS FEMUR WITH STEMS WAS CEMENTED. A SIGMA RP INSERT WAS INSERTED AND THE LCS PATELLA WAS RETAINED. SURGEON WAS HAPPY WITH RESULT. THE FEMUR LOOKED LIKE A POROUS LCS FEMUR. DOI: UNKNOWN. DOR: (B)(6) 2018 RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7446579 ↗