LCS COMPLETE 1294-09-850Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295022794), received between Feb 22, 2018 and Oct 17, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PATELLA POLY WORE OUT. NO LOT NUMBER WAS FOUND. NO DELAY IN SURGERY. ALL PIECES WE RECOVERED. NO ADDITIONAL INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23324911 ↗
• InjuryJun 27, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT LCS METAL BACKED POLY REPLACEMENT WAS DONE TODAY. POLY WAS WORN AND NEEDS TO BE REPLACED. NO IMPLANT RECORD WAS AVAILABLE. POLY SIZE WAS LEGIBLE BUT THE LOT NUMBER WAS NOT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19625378 ↗
• InjurySep 26, 2023Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO POLY WEAR. THE KNEE WAS DONE IN EARLY 90S AND NEEDED A POLY SWAP. DOI: EARLY 90S. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17816452 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9613503 ↗
• InjuryAug 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS RUPTURED QUADRICEPS MECHANISM AND RUPTURED PATELLAR TENDON DUE TO TWO FALLS. THE ITEMS WERE REMOVED FOR KNEE FUSION. DOI: (B)(6) 2018, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8951787 ↗
• InjuryMar 14, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATELLA CAP WAS WORN SO SURGEON REPLACED CAP AND PUT NEW INSERT IN KNEE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8421583 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DID A POLY SWAP. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7868644 ↗
• InjuryFeb 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION WITH POLY PATELLA AND INSERT EXCHANGE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7288326 ↗