SIGMA LCS COMPLETE POROCOAT 1294-32-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295025672), received between Jan 6, 2020 and Nov 9, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Migration; Migration

  LITIGATION COMPLAINT RECEIVED 24 OCT 2023 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2002, THE PATIENT HAD A LEFT NON-CEMENTED LCS TOTAL KNEE ARTHROPLASTY, TO ADDRESS LEFT KNEE MEDIAL FEMORAL CONDYLE CHONDRAL DEFECT WITH THE PATELLOFEMORAL CHONDRAL DEFECT. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2023 THE PATIENT HAD A LEFT TOTAL KNEE REVISION TO ADDRESS ARTHROPLASTY MECHANICAL FAILURE. THE SURGICAL FINDINGS INCLUDED TIBIAL SUBSIDENCE WITHOUT LOOSENING, AND PATELLAR BUTTON POLY WEAR. THE TIBIA WAS NOTED TO HAVE SUBSIDED 10MM. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI:(B)(6) 2002. DOR:(B)(6) 2023 (LEFT KNEE).

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18101182 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION AND SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO EITHER DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND PATELLA WERE REMOVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17216879 ↗
• MalfunctionJan 6, 2020Use of Device Problem; Use of Device Problem

  UPDATE 20 DEC 2019. MEDICAL RECORDS WERE REVIEWED TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. ON (B)(6) 2019, THE PATIENT PRESENTED FOR A LEFT KNEE EVALUATION DUE TO PAIN, DECREASED RANGE OF MOTION, INSTABILITY, AND DIFFICULTY WALKING FOLLOWING A FALL. THE PHYSICIAN SUSPECTED A POSSIBLE TIBIAL BONE FRACTURE AND POSSIBLE PATELLAR TENDON INJURY. AN X-RAY OF THE LEFT KNEE REVEALED A VALGUS ALIGNMENT OF ABOUT 3 DEGREES AS WELL AS A SMALL SCLEROTIC AREA ON THE TIBIA. THE PHYSICIAN INDICATED THE PATIENT WOULD UNDERGO AN MRI TO RULE OUT POSSIBLE INJURIES. THE PATIENT WAS PUT IN A KNEE IMMOBILIZER AND GIVEN CRUTCHES. THE PRIMARY OPERATIVE NOTE INDICATED TWO DEPUY CEMENT PRODUCTS WERE USED DURING THE PRIMARY OPERATION. THERE IS NO EVIDENCE OF REVISION OR INVASIVE INTERVENTION.

  Patient problems: Bone Fracture(s); Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9553908 ↗