LCS COMPLETE 1294-05-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295022091), received between May 1, 2018 and Jul 16, 2025 — classified as 24 injuries, 1 malfunction.

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

• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS BILATERAL POLY WASHOUT DUE TO INFECTION. THIS REPORT CAPTURES THE LEFT KNEE AND IS RELATED TO (B)(4), WHICH CAPTURES THE RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22519175 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A BILATERAL POLY WASHOUT DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22505757 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY TKR. PATIENT HAS RETURNED DUE THE TIBIAL TRAY SUBSIDING DUE TO A FALL AND IS NOW UNHAPPY WITH HER KNEE REPLACEMENT. FULL REVISION OF LCS TKR DONE AND ATTUNE REVISION IMPLANTED. SPECIMENS TAKEN EVEN THOUGH INFECTION IS NOT SUSPECTED. DOI: (B)(6) 2012. DOE: (B)(6) 2024. AFFECTED SIDE: LEFT.

  Patient problems: Fall

  MAUDE report 19108562 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS PRIMARY KNEE REPLACEMENT DUE TO EARLY OSTEOLYSIS OF THE FEMORAL AND TIBIAL COMPONENTS. SURGEON HAD A CONCERN AROUND A PATTERN OF LCS EARLY OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 18771525 ↗
• InjuryAug 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED AGAIN IN 2017 WITH PAIN & BONE SCANS SUGGESTING LOOSENING - REVISED ENTIRE CONSTRUCT TO TC3 WITH MBT SLEEVES & STEMS.

  Patient problems: Pain

  MAUDE report 17564719 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A WASHOUT OF THE KNEE DUE TO INFECTION WITH POLY EXCHANGE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIG.HT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17039326 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. ALL COMPONENTS WERE WELL FIXED. LOOSE LIGAMENTS WERE STABILIZED WITH INCREASING INSERT THICKNESS. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16672873 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? IT IS THE LEFT KNEE. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR OR JUST LACK OF PCL? LACK OF PCL. C. CAN YOU CONFIRM, IF DEPUY CEMENT WAS USED, DURING THE PRIMARY SURGERY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS OF THE CEMENT. QUANTITY OF THE DEPUY CEMENT USED. CANNOT DETERMINE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 16487967 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT TKR IN 2019. PRESENTED BACK TO SURGEON COMPLAINING OF INSTABILITY IN KNEE WHEN USING THE STAIRS. PROCEDURE LEFT INSERT EXCHANGE LCS TI NI TKR. SURGEON REMOVED EXISTING 12.5MM STANDARD PLUS INSERT. TRIALED A 15MM INSERT, SURGEON SATISFIED WITH STABILITY AND RANGE OF MOTION, 15MM STANDARD PLUS INSERT IMPLANTED. DOI: 2019, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Joint Laxity

  MAUDE report 15581393 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF INSTABILITY. NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 14307496 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT WAS EXTRACTED FROM THE FILE "SERVICE EVALUATION OF THE LCS TINI PRODUCT - FINAL REPORT". Q4. REVISIONS AND PRIMARY REASONS FOR REVISION: 10X TKR REVISIONS. INFECTION (5X). 1X NEW ( EXTERNAL REVISION). DOI: (B)(6) 2011, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13513751 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT LCS TKR IN 2015. PRESENTED WITH SWELLING AND PAIN LEFT KNEE, INFECTION. PATIENT UNDERWENT DEBRIDEMENT, WASHOUT AND EXCHANGE OF POLY LEFT TKR-LCS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain; Swelling/ Edema

  MAUDE report 11598676 ↗
• InjuryApr 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT HAS NOT BEEN HAPPY WITH KNEE SINCE IT WAS IMPLANTED AND COMPLAINING OF PAIN. SURGEON HAD SCANS OF THE KNEE DONE, AND SOME HOT SPOTS SHOWED UP AROUND THE KNEE. SURGEON THOUGHT MAYBE THE IMPLANT WAS LOOSE. WHEN REMOVING THE IMPLANT, THE SURGEON STATED THE IMPLANT WAS NOT LOOSE BUT STILL REMOVED DUE TO PATIENTS REQUEST.

  Patient problems: No Code Available; Pain

  MAUDE report 9954211 ↗
• MalfunctionApr 6, 2020Difficult to Insert; Device-Device Incompatibility; Difficult to Insert; Device-Device Incompatibility

  IT WAS REPORTED THAT A 1294-05-512 WAS OPENED AND INSERTED ONTO THE TRAY. IT DID NOT FIT, IT SAT UP ABOUT 3MM. UPON CLOSER EXAMINATION OF THE TRAY, IT WAS THE OLD FIGURE 8 TRAY. IT WAS THE WRONG POLY. IT WAS ALSO REPORTED THAT A 129409850-3 PEG METAL BACKED PATELLA POLY REPLACEMENT WAS OPENED AND IT DID NOT FIT THE METAL BACK PATELLA COMPONENT. SURGEON PUT THE REMOVED INSERT AND PATELLA BACK IN AND CLOSED THE PATIENT UP. THEY WILL HAVE TO GO BACK IN ON FRIDAY TO COMPLETE THE SURGERY. DOE: (B)(6) 2020. LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 9930266 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE AND STABILITY ISSUES. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION COMPONENTS WERE IMPLANTED. THE LOT NUMBERS ON THESE EXPLANTED COMPONENTS WERE NOT LEGIBLE EXCEPT FOR THE POLYETHYLENE BEARING. PRECOATED IMPLANTS WERE USED. DOI: UNKNOWN. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9467184 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SYMPTOMS CONSISTENT WITH INFECTION OF THE TOTAL KNEE. THE PATIENT HAD A FEVER AND THE OPERATIVE KNEE WAS RED AND SWOLLEN. SURGEON DREW LABS AND ASPIRATED THE KNEE. THE LABS WERE ELEVATED CONSISTENT WITH INFECTION, ALSO THE ASPIRATE GREW OUT BACTERIA. SURGEON THEN TOOK THE PATIENT TO SURGERY TO REMOVE THE IMPLANTS TO WASHOUT AND PLACE ANTIBIOTIC SPACER. IMPLANTS WERE ALL WELL FIXED. IMPLANTS WERE REMOVED WITH VERY LITTLE BONE LOSS. ANTIBIOTIC SPACERS WERE PLACED. DEPUY CEMENT WAS USED. UPDATE: DEPUY 2 CEMENT REF# 3322020 LOT# 8770435 WAS USED DURING THE PRIMARY KNEE PROCEDURE ON (B)(6) 2019 TO CEMENT THE TIBIA AND PATELLA. THE IMPLANTS WERE FOUND TO BE WELL FIXED AT THE TIME OF THE EXPLANT PROCEDURE. DOI: (B)(6) 2019; DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Fever; Injury; No Code Available; Swelling; Unspecified Infection

  MAUDE report 8451086 ↗
• InjuryMar 25, 2019Naturally Worn; Naturally Worn

  CHANGED OUT INSERT AND MODULAR PATELLA DUE TO WEAR.

  Patient problems: No Code Available

  MAUDE report 8448543 ↗
• InjuryDec 7, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY WORN.

  Patient problems: No Code Available

  MAUDE report 8142465 ↗
• InjuryNov 15, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8073828 ↗
• InjurySep 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. IT WAS ALSO REPORTED THAT THE FEMUR, POLY AND TRAY WERE ALL REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7854721 ↗
• InjuryJun 14, 2018Naturally Worn; Naturally Worn

  REVISION DUE TO PAIN, INSTABILITY, AND POLY WEAR.

  Patient problems: Not Applicable; Pain

  MAUDE report 7601493 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATELLA RESURFACING AND INSERT EXCHANGE; (B)(6) 2018. PATIENT WAS SUFFERING FROM GENERAL "INSTABILITY" IN THE KNEE, AND WAS ALSO COMPLAINING OF ANTERIOR KNEE PAIN. SURGEON ELECTED TO REVISE THE INSERT TO A THICKER ONE, AND ALSO RESURFACED THE PATELLA. PATIENT INITIALS: (B)(6).

  Patient problems: Joint Disorder; Not Applicable; Pain

  MAUDE report 7560586 ↗
• InjuryMay 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN DUE TO INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7536929 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION KNEE; DR (B)(6), (B)(6), (B)(6) 2018. TIBIAL INSERT AND PATELLA INSERT CHANGED FOR AN INFECTED KNEE WITH WOUND BREAKDOWN. PATIENT HAD ORIGINAL KNEE REPLACEMENT 6 WEEKS AGO. ACTUAL OPERATION DATE UNKNOWN, NO X-RAY'S OR PATIENT NOTES AVAILABLE. FEMALE PATIENT INITIALS: KM, AGED (B)(6) YEARS, DOB: (B)(6), WEIGHT: (B)(6) KG, HEIGHT: 155 CM. DOI: 6 WEEKS AGO; DOR: (B)(6) 2018; UNKNOWN KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7511098 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7475262 ↗