LCS COMPLETE 1294-05-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10603295022152), received between Aug 2, 2017 and Apr 29, 2026 — classified as 65 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (17 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2008, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 25033488 ↗
• InjuryFeb 26, 2026Fracture

  IT WAS REPORTED ON (B)(6) 2019 THE A PATIENT RECEIVED A LCS® COMPLETE¿ TOTAL KNEE PROSTHESIS (DEPUY) ON (B)(6) 2019, APPROXIMATELY FIVE WEEKS AFTER IMPLANTATION, FOLLOWING A REHABILITATIVE PHYSIOTHERAPY SESSION, THE PATIENT EXPERIENCED A SUDDEN ACUTE PAIN IN THE OPERATED KNEE. SUBSEQUENT RADIOGRAPHIC AND CLINICAL EXAMINATIONS ((B)(6) 2019) REVEALED FRACTURE OF THE POLYETHYLENE TIBIAL INSERT, REQUIRING SURGICAL REVISION ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 24454267 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS BEARING DUE TO INSTABILITY. THE BEARING THICKNESS NEEDED TO BE THICKER TO INCREASE STABILITY. BEARING WAS UPSIZED FROM 10MM TO 15MM. NO OTHER COMPONENTS WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 24292029 ↗
• InjurySep 23, 2025Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: REVISION SURGERY WAS COMPLETED WITH A POLYETHYLENE LINER EXCHANGE CURRENTLY LCS POLYETHYLENE IS MADE FROM NON-X-LINKED MATERIAL - SO THERE IS NOT A X-LINED OPTION AVAILABLE. SURGEON HAS REQUESTED THAT THEY BE MANUFACTURED FROM X-LINKED POLYETHYLENE MOVING FORWARD.

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 23125279 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT REQUIRED A WASHOUT AND POLY EXCHANGE ON AN INFECTED LEFT TKR. IT WAS NOTED THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Unspecified Infection

  MAUDE report 22337507 ↗
• InjuryApr 29, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD LCS POLY EXCHANGE DUE TO WORN POLY AND UNSTABLE KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21925732 ↗
• MalfunctionJun 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE INSERT FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582952 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS TOTAL KNEE. REVISION DUE TO INSTABILITY AND PAIN. METALLOSIS WAS ALSO NOTED IN THE JOINT.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 19088758 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO DELAY.

  Patient problems: Pain

  MAUDE report 18865868 ↗
• InjuryFeb 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS KNEE DONE IN [YEAR]. LEFT. REASON FOR REVISION WAS DUE TO INSTABILITY. FEMUR AND TIBIA WERE NOT LOOSE AND WERE WELL FIXED. ALL COMPONENTS WERE REMOVED, AND ATTUNE REVISION WITH S-ROM NOILES WAS IMPLANTED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, IP-01957098 DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, IP-01957099 DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Joint Laxity

  MAUDE report 18682697 ↗
• InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LCS KNEE REVISION DUE TO OSTEOLYSIS. ADDITIONAL EVENT INFORMATION: ALL 3 DEVICES WERE EXPLANTED ON (B)(6) 2024. EXPLANTED DUE TO OSTEOLYSIS WHICH REQUIRED REVISION SURGERY. REVISION SURGERY ON (B)(6) 2024. DATE OF ORIGINAL IMPLANT 2006.

  Patient problems: Osteolysis

  MAUDE report 18579108 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2005. DOR: (B)(6) 2024. RIGHT KNEE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? YES. IF YES, DESCRIBE: REVISION SURGERY. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. (B)(4). DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 18453206 ↗
• InjuryJan 4, 2024Naturally Worn; Naturally Worn

  REVISION OF BILATERAL LCS POLY INSERTS ON A LCS TKR. WEAR AND TEAR OF THE INSERTS OVER THE [YEARS], PATIENT HAD REPORTED TO THE SURGEON THAT HIS PATELLA'S WERE FEELING SORE AND THAT'S WHERE THE PAIN WAS LOCATED ON THE SCAN. SCANS SHOWED NO HOT SPOTS OF LOOSENING ON THE FEMUR OR THE TIBIA, JUST ON THE PATELLAS. THE PATELLA'S AT THE ORIGINAL PRIMARY SURGERY WHERE NOT REPLACED AND REMAINED NATURAL UNTIL NOW. (B)(4) ARE RELATED TO CAPTURE THE BILATERAL REVISION OF LCS POLY INSERTS. AS IT WAS NOT CONFIRMED WHICH PRODUCT USED IN WHICH SIDE, FOLLOW UP WAS INITIATED TO CONFIRM THAT. FOR NOW, IT WAS ASSUMED THAT (B)(4) CAPTURES THE LEFT KNEE AND (B)(4)CAPTURES THE RIGHT KNEE.

  Patient problems: Discomfort; Pain

  MAUDE report 18443283 ↗
• InjuryDec 28, 2023Naturally Worn; Naturally Worn

  REVISION OF BILATERAL LCS POLY INSERTS ON A LCS TKR DONE 16 YEARS AGO. WEAR AND TEAR OF THE INSERTS OVER TIME, PATIENT HAD REPORTED TO THE SURGEON THAT HIS PATELLA'S WERE FEELING SORE AND THAT IS WHERE THE PAIN WAS LOCATED ON THE SCAN. SCANS SHOWED NO HOT SPOTS OR LOOSENING ON THE FEMUR OR THE TIBIA, JUST ON THE PATELLA'S. THE PATELLA'S AT THE ORIGINAL PRIMARY SURGERY WERE NOT REPLACED AND REMAINED NATURAL UNTIL NOW. INSERTS WERE CHANGED DUE THEM BEING IN FOR SEVERAL YEARS.

  Patient problems: Discomfort; Pain

  MAUDE report 18410507 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. DOI: (B)(6) 2003. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17703328 ↗
• InjurySep 6, 2023Naturally Worn; Naturally Worn

  INLAY REPLACEMENT LCS COMPLETE MOBILE DUE TO A LOT OF POLY WEAR. DOI: UNKNOWN. DOE: (B)(6) 2023. AFFECTED SIDE:

  Patient problems: Insufficient Information

  MAUDE report 17690020 ↗
• InjuryJun 13, 2023Naturally Worn; Naturally Worn

  THE PATIENT HAD UNDERGONE LEFT KNEE REPLACEMENT IN 2004 BY A PRIMARY SURGEON IN LAPEER MICHIGAN. THE PATIENT HAS DONE WELL UNTIL RECENTLY, WHERE HIS KNEE HAS BECOME UNSTABLE. THE REVISING SURGEON REVISED THE KNEE ON (B)(6) 2023 AND EXPLANTED THE PATIENT'S LCS LARGE 10MM INSERT. THE LCS TIBIAL TRAY, FEMORAL COMPONENT, AND METAL BACKED 3 PEG PATELLA WAS LEFT IN SITU. THE PART AND LOT NUMBERS FOR THE IMPLANTS LEFT IN SITU COULD NOT BE RETRIEVED. THE LCS COMPLETE INSERT THAT WAS EXPLANTED DISPLAYED DELAMINATING, WEAR, AND WAS OXIDIZED. A NEW 10MM INSERT WAS IMPLANTED. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2004. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17117013 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF WELL FIXED LCS PRIMARY COMPONENTS DUE TO UNEXPLAINED PAIN. ATTUNE REVISION USED FOR REPLACEMENT WITH PATELLA RESURFACED.

  Patient problems: Inflammation; Pain

  MAUDE report 16673036 ↗
• InjuryFeb 10, 2023Fracture; Naturally Worn; Fracture; Naturally Worn

  PATIENT REPORTEDLY HAD A FALL 6 MONTHS AGO, HOWEVER SURGEON THOUGHT IT COULD BE STRESS SHIELDING. THE LCS FEMORAL IMPLANT HAS SNAPPED. DID THE EVENT OCCUR DURING STERILE PROCESSING? UNKNOWN. DID THE EVENT OCCUR DURING FIELD INSPECTION? UNKNOWN. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? NEEDED REVISION SURGERY, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE X RAYS , IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-01438675. DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF HOSPITAL BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Fall

  MAUDE report 16350775 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED DUE TO PAINFUL KNEE. DID A POLY EXCHANGE AND SYNOVECTOMY. ALSO CHANGED THE PLASTIC ON THE LCS CRUCIFORM PATELLA BUT NO NUMBERS COULD BE SEEN. THERE WAS NO SURGICAL DELAY AND NO FURTHER INFORMATION WAS AVAILABLE. DOI: (B)(6) 2003, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15145951 ↗
• InjuryJul 28, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN - UNRESURFACED PATELLA. POLY EXCHANGE FOR AGE. DOI: 2011, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 15122122 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A LCS KNEE IMPLANT DUE TO PAIN. DOI: UNK. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15013816 ↗
• InjuryJun 8, 2022Naturally Worn; Naturally Worn

  PT EXPERIENCED PAIN AND SWELLING POST PRIMARY TKR. IMPLANTED SIZE LARGE FEMUR, 10MM POLY, SIZE 5 MBT. KNEE REVISED (B)(6) 2022. DOI: (B)(6) 2014. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 14631776 ↗
• InjuryJun 2, 2022Naturally Worn; Naturally Worn

  POLY-CHANGE LCS RP DUE TO LAXITY. A LOT OF POLYWEAR. DELAMINATION. DOI: (B)(6) 2012. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14577520 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO AN UNSTABLE KNEE AND LOOSENING OF THE FEMORAL AND THE TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2012. DOE: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13693642 ↗