LCS COMPLETE POROCOAT 1294-04-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295021780), received between Oct 19, 2017 and Sep 28, 2023 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2008. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17836100 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT EXPERIENCED PAIN AND SWELLING POST PRIMARY TKR, IMPLANTED SIZE LARGE FEMUR, 10MM POLY, SIZE 5 MBT, KNEE REVISED (B)(6) 2022. DOI: (B)(6) 2014, DOR: (B)(6) 2022, UNKNOWN KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14631801 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13505593 ↗
• InjuryDec 10, 2021Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TIBIAL COMPONENT WAS LOOSE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12976021 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Muscular Rigidity

  MAUDE report 12595515 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN FOLLOWING A CYST THAT FORMED ON THE LATERAL FEMORAL CONDYLE. THIS NECESSITATED THE REMOVAL OF THE PROSTHESIS.

  Patient problems: Cyst(s); Pain

  MAUDE report 11738126 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MCL DEFICIENT. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11212844 ↗
• InjuryOct 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS STIFF AND PAINFUL KNEE. REVISION WAS PERFORMED INCLUDING SOFT TISSUE DEBRIDEMENT AND REMOVAL OF OSTEOPHYTES. ALSO, THE PRIMARY PROCEDURE WAS PERFORMED 12 YEARS AGO AND PATIENT ACTIVITY LEVELS: ACTIVITY DECREASED DUE TO STIFF KNEE.

  Patient problems: Pain

  MAUDE report 6982451 ↗
• InjuryOct 19, 2017Noise, Audible; Noise, Audible

  PATIENT WAS IMPLANTED IN (B)(6) 2007. (B)(6) 2013 PAIN AND STIFFNESS WITH AUDIBLE SQUEAKING. (B)(6) ¿ 1ST STAGE REVISION AS A PRECAUTION NO EVIDENCE OF INFECTION. (B)(6) - 2ND STAGE REVISION.

  Patient problems: Pain

  MAUDE report 6962911 ↗