LCS COMPLETE 1294-05-415Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295022039), received between Oct 20, 2017 and Dec 29, 2022 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 29, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THE LCS FEMUR MEDIAL CONDYLE AREA FRACTURED AFTER INITIAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16068977 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 14593752 ↗
• InjuryApr 14, 2022Unintended Movement; Unintended Movement

  REVISION COMPLETED DUE TO INSTABILITY AND POLY SPIN OUT. NO SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14112325 ↗
• MalfunctionAug 31, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INSTRUMENTS AND IMPLANTS THAT WERE SEND OUT TO THE CUSTOMER DID NOT FIT IN THE KNEE THAT WAS IN SITU. PROCEDURE WAS ABORTED AND PATIENT HAD TO BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12390961 ↗
• InjuryApr 30, 2021Naturally Worn; Naturally Worn

  PRIMARY LCS TKR 2003 SAN 12.5MM ACTUAL DATE UNKNOWN 2003 IS ONLY DATA REVISED FOR INSTABILITY 2011 TO 15MM POLY REVISED TODAY FOR INSTABILITY POLY WEAR -INCREASED POLY TO 20MM.

  Patient problems: Joint Laxity

  MAUDE report 11758036 ↗
• InjuryJul 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. POLY EXCHANGE WAS PERFORMED. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10246330 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. WASH OUT AND POLY EXCHANGE WERE PERFORMED. NO SURGICAL DELAY NOTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10239719 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY.

  Patient problems: No Code Available

  MAUDE report 9571090 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PAIN. A REPLACEMENT WITH A THICKER INSERT WAS DONE. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8594934 ↗
• MalfunctionNov 9, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE PACKAGING WAS DAMAGED AND APPEARED UNSTERILE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055405 ↗
• InjuryDec 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND TOTAL KNEE WASH OUT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 7141803 ↗
• InjuryOct 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 6965093 ↗