LCS COMPLETE 1294-05-410Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295022015), received between Sep 6, 2017 and Mar 5, 2026 — classified as 61 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (15 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 63 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. THEY DID A POLY SWAP. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24518153 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHOUTENS C, NOLTE PA, VAN NOORT A. TRAUMATIC ANTERIOR TIBIOFEMORAL DISLOCATION OF MOBILE-BEARING TOTAL KNEE ARTHROPLASTY: TWO CASES. TRAUMA CASE REP. 2025 FEB 17;56:101144. DOI: 10.1016/J.TCR.2025.101144. PMID: 40083388; PMCID: PMC11904596. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS 2 CASES; CASE 1: A 71-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A FALL FROM STANCE ONTO THE FLOOR IN THE DOMESTIC SETTING, IN WHICH HYPEREXTENSION OF HER LEFT PROSTHETIC KNEE JOINT HAD PROBABLY OCCURRED. A LCS COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED FIFTEEN YEARS PRIOR FOR SYMPTOMATIC LATERAL OSTEOARTHRITIS. CASE 2: A 73-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY ROOM AFTER SLIPPING ON AN OIL SPILL AND FALLING DIRECTLY ONTO HER LEFT KNEE. SHE WAS IN SEVERE PAIN, COULD NOT BEAR WEIGHT, AND HAD A DEFORMED LEFT KNEE JOINT. A LEFT LSC COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED 8 YEARS PRIOR FOR SYMPTOMATIC OSTEOARTHRITIS IN AN UNCOMPLICATED PROCEDURE. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 23630383 ↗
• InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHOUTENS C, NOLTE PA, VAN NOORT A. TRAUMATIC ANTERIOR TIBIOFEMORAL DISLOCATION OF MOBILE-BEARING TOTAL KNEE ARTHROPLASTY: TWO CASES. TRAUMA CASE REP. 2025 FEB 17;56:101144. DOI: 10.1016/J.TCR.2025.101144. PMID: 40083388; PMCID: PMC11904596. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS 2 CASES; CASE 1: A 71-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A FALL FROM STANCE ONTO THE FLOOR IN THE DOMESTIC SETTING, IN WHICH HYPEREXTENSION OF HER LEFT PROSTHETIC KNEE JOINT HAD PROBABLY OCCURRED. A LCS COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED FIFTEEN YEARS PRIOR FOR SYMPTOMATIC LATERAL OSTEOARTHRITIS. CASE 2: A 73-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY ROOM AFTER SLIPPING ON AN OIL SPILL AND FALLING DIRECTLY ONTO HER LEFT KNEE. SHE WAS IN SEVERE PAIN, COULD NOT BEAR WEIGHT, AND HAD A DEFORMED LEFT KNEE JOINT. A LEFT LSC COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED 8 YEARS PRIOR FOR SYMPTOMATIC OSTEOARTHRITIS IN AN UNCOMPLICATED PROCEDURE. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 23630355 ↗
• InjuryNov 7, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS POLY WEAR OVER TIME. IT IS NOT KNOWN EXACTLY WHEN THE PRIMARY SURGERY WAS PERFORMED. SURGEON INCREASED POLY THICKNESS. THERE WAS NO DELAY AND NO HARM TO PATIENT. NO FURTHER INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23495903 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POLY EXCHANGE DURING PATELLA REPLACEMENT DUE TO INSTABILITY. ADDITIONALLY, THE PATIENT EXPERIENCED PATELLA PAIN REQUIRING PATELLA REPLACEMENT. NO STANDARD WEAR ON POLY AFTER REMOVAL.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23466930 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INSERTED WITH LCS IN LEFT KNEE. SURGEON FOUND THAT THE KNEE WAS INFECTED AND DECIDED TO REPLACE THE INSERT (LCS HP COMPLETE INSERT - STD 10 MM).

  Patient problems: Unspecified Infection

  MAUDE report 23369156 ↗
• InjuryOct 20, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED ON A TIBIAL POLY WEAR. THE LCS COMPLETE KNEE WAS DONE 20+ YEARS AGO. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23342635 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD DEBRIDEMENT AND CONTRACTURE RELEASE WHICH INCREASED FLEXION TO 85 DEGREES BUT IT THEN STIFFENED UP AGAIN TO ONLY ABOUT 45 DEGREES OF FLEXION. REVISION OF LCS IMPLANTS WHICH WERE IMPLANTED. REVISION DUE TO STIFFNESS, PARTICULARLY GOING UP AND DOWN STAIRS WHICH WAS DEVELOPED POSTOPERATIVELY. THIS WASN'T AN ISSUE INITIALLY POTS OP BUT DEVELOPED OVER TIME. THE PATIENT HAD DEBRIDEMENT AND CONTRACTURE RELEASE WHICH INCREASED FLEXION TO 85 DEGREES BUT IT THEN STIFFENED UP AGAIN TO ONLY ABOUT 45 DEGREES OF FLEXION. THIS WAS HER RIGHT KNEE, NO ISSUES WITH THE LEFT KNEE WHICH NOTES MENTIONED HAD ALSO HAD A TKA. NO PAIN IN LEFT OR RIGHT KNEE. SIZES IN SITU FROM LCS WERE 2.5 TIBIA, 10MM INSERT AND STANDARD FEMUR. INITIAL NOTES POST OP WERE STABLE AND WELL-BALANCED KNEE BUT LATERAL RETINACULAR STRUCTURES WERE TIGHT. NO WEAR WAS OBSERVED ON THE INSERT. A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI (THIS WAS OVER 45 AND WE WERE INFORMED IT WAS SIMILAR CURRENTLY). FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM (WHICH COULDN'T BE SEEN IN THE X-RAY TAKEN), THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TOURNIQUET WAS REMOVED AND THE LEG MOV

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 22586242 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION OF LCS IMPLANTS. REVISION DUE TO STIFFNESS, PARTICULARLY GOING UP AND DOWN STAIRS WHICH WAS DEVELOPED POSTOPERATIVELY. THIS WASN'T AN ISSUE INITIALLY POST OP BUT DEVELOPED OVER TIME. THE PATIENT UNDERWENT DEBRIDEMENT AND CONTRACTURE RELEASE WHICH INCREASED FLEXION TO 85 DEGREES BUT IT THEN STIFFENED UP AGAIN TO ONLY ABOUT 45 DEGREES OF FLEXION. THIS WAS HER RIGHT KNEE, NO ISSUES WITH THE LEFT KNEE WHICH NOTES MENTIONED HAD ALSO HAD A TKA. NO PAIN IN LEFT OR RIGHT KNEE. SIZES IN SITU FROM LCS WERE 2.5 TIBIA, 10MM INSERT AND STANDARD FEMUR. INITIAL NOTES POST OP FROM [YEAR] WERE STABLE AND WELL-BALANCED KNEE BUT LATERAL RETINACULAR STRUCTURES WERE TIGHT. NO WEAR WAS OBSERVED ON THE INSERT. A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM (WHICH COULDN'T BE SEEN IN THE X-RAY TAKEN), THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TORNIQUET WAS REMOVED AND THE LEG MOVED POST OP.

  Patient problems: Muscular Rigidity

  MAUDE report 22529993 ↗
• InjuryJun 12, 2025Naturally Worn; Naturally Worn

  REVISING LCS COMPLETE KNEE FOR POLY WEAR AND SYNOVITIS. FEMUR IMPLANT CAME OFF UNDER RETRACTION. SURGEON ELECTED TO REVISE ALL COMPONENTS. FEMUR WAS LOOSE AT BONE TO CEMENT INTERFACE. DOI: UNKNOWN . DOR: (B)(6) 2025 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Synovitis

  MAUDE report 22197427 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A SURGERY THREE WEEKS PRIOR AND DEVELOPED AN INFECTION IN THE KNEE. NO DELAY IN SURGERY. DOI: (B)(6) 2012. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21635514 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2007, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20930109 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO PATIENT HARM OR NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 20848851 ↗
• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. PLEASE CLARIFY IF THERE IS ANY INFECTION. NOTHING COULD BE SEEN, I HAVE NOT HEARD IF THERE WAS ANY INFECTION PRESENT. B. PLEASE CLARIFY WHAT HAPPENED DURING REVISION ¿ POLY WAS REMOVED, KNEE WASHOUT OCCURRED WITH 9L OF SALINE, STERILE BETADINE AND PEROXIDE ALSO USED.

  Patient problems: Unspecified Infection

  MAUDE report 19449418 ↗
• InjuryApr 17, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA WITH THE IMPLANT IN QUESTION. IT WAS CONFIRMED THAT THE IMPLANT IN QUESTION WAS SPUN OUT ON (B)(6) THE REVISION SURGERY IS SCHEDULED FOR (B)(6) NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19127876 ↗
• InjuryJan 9, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  THE PATIENT WAS REVISED AS THE POLY HAD WORN IN TWO PIECES. THE WEAR WAS ON POSTERIOR MEDIAL SIDE. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN DOR: (B)(6). 2024 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18475042 ↗
• InjuryNov 17, 2023Naturally Worn; Naturally Worn

  PATIENT'S POLY WAS EXCHANGED DUE TO POLY WEAR. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18161899 ↗
• InjuryNov 9, 2023Naturally Worn; Naturally Worn

  LITIGATION COMPLAINT RECEIVED (B)(6) 2023 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2002, THE PATIENT HAD A LEFT NON-CEMENTED LCS TOTAL KNEE ARTHROPLASTY, TO ADDRESS LEFT KNEE MEDIAL FEMORAL CONDYLE CHONDRAL DEFECT WITH THE PATELLOFEMORAL CHONDRAL DEFECT. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2023 THE PATIENT HAD A LEFT TOTAL KNEE REVISION TO ADDRESS ARTHROPLASTY MECHANICAL FAILURE. THE SURGICAL FINDINGS INCLUDED TIBIAL SUBSIDENCE WITHOUT LOOSENING, AND PATELLAR BUTTON POLY WEAR. THE TIBIA WAS NOTED TO HAVE SUBSIDED 10MM. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI:(B)(6) 2002, DOR:(B)(6) 2023, (LEFT KNEE).

  Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury

  MAUDE report 18101185 ↗
• InjuryNov 7, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18085475 ↗
• InjuryAug 18, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED. THIS WAS A RIGHT-SIDE REVISION. THERE WAS ORIGINALLY NOT IMPLANTED PATELLA IN SITU PRIOR TO THE REVISION. SO THE PATELLA PORTION WAS JUST A RESURFACING. THERE WERE NO ADVERSE EFFECTS OF THE POLY WEAR ON THE PATIENT (MINUS SOME INSTABILITY DUE TO EXTREME POLY WEAR). THE KNEE WAS ABLE TO BE REBALANCED IN THE REVISION WITH THE INSERTION OF A NEW POLY.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 17571353 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLANNED REVISION IN (B)(6) 2023, CHANGE INLAY TO A CUSTOM MADE INLAY, FROM LCS STD 10MM TO LCS STD 8MM.

  Patient problems: Joint Contracture

  MAUDE report 17189920 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE PAIN AND INSTABILITY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16252035 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A PAINFUL KNEE. DID A SYNOVECTOMY AND A POLY EXCHANGE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2005. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16113137 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF LCS IMPLANT AND REVISION TO ATTUNE REVISION. DISCUSSED THIS WITH THE SURGEON WHO STATED THE REVISION WAS DUE TO THE PATIENTS LACK OF MCL AND NOT BECAUSE THE LCS HAD FAILED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15690691 ↗
• InjuryOct 27, 2022Fracture; Naturally Worn; Fracture; Naturally Worn

  LCS COMPLETE STD POLY AND PATELLA REVISION PATIENT WAS EXPERIENCING PAIN DUE TO DELAMINATION AND WEAR OF THE POLY AND OXIDISATION. AS A RESULT REQUIRED REMOVAL OF OLD POLY AND INSERTION OF NEW. WHILST INTRAOP LOOSE BIT OF THE OLD POLY INSERT DUE TO THE DELAMINATION FOUND POSTERIOR IN PATIENTS TISSUE. DOI: (B)(6) 2005. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15680508 ↗