LCS COMPLETE 1294-05-612Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295022169), received between Apr 12, 2018 and Sep 30, 2026 — classified as 24 injuries, 1 malfunction.

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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient of retired surgeon had a LCS complete total knee. No implant record available so no known surgery date. Patient was brought in for acute infection of left knee. Washout and poly swap performed of the tibial insert and patella poly. No item number or lot number stamped on the patella poly. Only the size was etched. Case done without issue. No additional information available.DOI-Unknown.DOR-(b)(6)2026.Affected side-Right knee.

  Patient problems: Unspecified Infection

  MAUDE report 50945238 ↗
• InjuryDec 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED A REVISION SURGERY FOR A LCS BEARING EXCHANGE IS REQUIRED DUE TO THE BEARING BECOMING WORN. REVISION WAS PERFORMED (B)(6) 2025. PATIENT HAS HAD A VERY HIGH BMI FOR A LONG PERIOD OF TIME WHICH LIKELY PLACED ADDITIONAL LOAD ON THE BEARING/ JOINT REPLACEMENT. IMPLANTS HAD BEEN INSITU FOR OVER 20 YEARS. ONLY THE LINER WAS EXCHANGED.

  Patient problems: Insufficient Information

  MAUDE report 23907382 ↗
• InjuryJan 31, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO SURGICAL DELAY. NO ALLEGATIONS AGAINST THE TRAY OR POLY.

  Patient problems: Insufficient Information

  MAUDE report 21285286 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY EXCHANGE LCS FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19174000 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO IRRIGATION AND DEBRIDEMENT (I&D) POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19118266 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? B. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? C. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? D. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? A. POLY DID NOT LOOK TO BE IN BAD SHAPE. B. NO. C. NO. D. I DO NOT BELIEVE SO.

  Patient problems: Joint Laxity

  MAUDE report 18586390 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION LEFT KNEE. PRIMARY IMPLANTS - RIGHT LCS FEMUR, 12.5MM INSERT AND SIZE 5 TIBIA. REVISION FOR SUBSIDENCE AND LOOSENING OF COMPONENTS. FEMUR REMOVED BY HAND - CLEAN (CEMENT LEFT ON BONE - NO CEMENT DETAILS AVAILABLE). TIBIA REMOVED VERY EASILY AS WELL WITH CEMENT ALL ATTACHED TO BONE AND NOT IMPLANT. DARK METALLOSIS APPEARED ON KNEE TISSUE, NO SIGNS OF INFECTION. SURGEON WASHED, DEBRIDED THEN REVISED USING ATTUNE REVISION.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18383112 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS VERY SEPTIC (INFECTION IN THEIR BODY) AND THE SURGEON WASHED OUT HIS JOINT AND REPLACED THE POLY. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: UNKNOWN, AND DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18235961 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRE OP DIAGNOSIS SHOWS SEPTIC JOINT, RIGHT KNEE. NEW LCS POLY WAS IMPLANTED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17895842 ↗
• InjuryJul 27, 2023Naturally Worn; Naturally Worn

  IN CASES OF PRONOUNCED OSTEOLYSIS, A PERIPROSTHETIC FRACTURE OCCURRED, WHICH IS WHY A COMPLEX PROSTHESIS EXCHANGE BECAME NECESSARY. ABRASION - INLAY, MASSIVE OSTEOLYSIS. DOI: UNKNOWN. DOE: UNKNOWN. AFFECTED SIDE: UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 17404253 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED LEFT TOTAL LCS KNEE THAT HE HAS FALLEN ON AND STRETCHED HIS MCL. THE SURGEON DID A WASHOUT AND TIBIAL INSERT EXCHANGE. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 16951988 ↗
• MalfunctionOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OF LCS FROM 2012. THE POSTERIOR CONDYLE OF THE FEMUR HAS FRACTURED OFF IN SITU. VISUALISED ON XRAY AND CT AND FOUND IN SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15670021 ↗
• 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 13505599 ↗
• 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 12595513 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. A WASHOUT AND POLY EXCHANGE WAS DONE. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT KNEE.

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

  MAUDE report 12367115 ↗
• InjuryMar 31, 2021Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE LEFT SIDE. DEPUY CMW 2 GENTAMICIN BONE CEMENT WAS USED. PATELLA IS NOT WORN.

  Patient problems: Pain

  MAUDE report 11596510 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION DOCTOR DID A WASHOUT AND POLY EXCHANGE. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

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

  MAUDE report 11090459 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. EXPLANTED COMPONENTS AND PUTTING IN STATIC SPACER WAS DONE. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10540162 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ORIGINAL SURGERY DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10057110 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR: PAIN AND INSTABILITY. THE PATIENT HAS REPORTED THAT THE KNEE HAS NEVER BEEN GOOD, AND HAS GOT WORSE OVER THE LAST FEW YEARS. HE HAS ANTERIOR KNEE PAIN WHICH RADIATES TO THE PERIPATELLAR REGIONS. THE KNEE FEELS WEEK AND GIVES WAY. MORE PAIN ON ACTIVITY. THE PATELLA TRACKS LATERALLY AND HAS NOT BEEN RESURFACED. HE HAS SIGNIFICANT PATELLA CREPITUS.

  Patient problems: No Code Available; Pain

  MAUDE report 9857069 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND SCAR TISSUE. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available; Osteolysis

  MAUDE report 9770039 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. A WASHOUT AND POLY REPLACEMENT WERE DONE. DOI: (B)(6) 2019; DOR: (B)(6) 2020; RT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9672357 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8146313 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE DUE TO INSTABILITY. SWAPPED INSERT FOR A LARGER SIZE. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7956165 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TKR; DR (B)(6) - (B)(6) (B)(6) 2018. PRIMARY KNEE REPLACEMENT PERFORMED ON (B)(6) 2018 AND REVISED DUE TO INFECTION (B)(6) 2018. MALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7425055 ↗