LCS COMPLETE 1294-09-660Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295022664), received between May 10, 2018 and Sep 23, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS HAD A KNEE REPLACEMENT- ON- (B)(6) 2021. STARTED HAVING ISSUES UNABLE TO DO PHYSICAL THERAPY DUE TO EXTREME PAIN. WENT 9 MONTHS UNTIL HE HAD AN ADDITIONAL SURGERY. HE HAD TO HAVE A SECOND SURGERY ON THIS SAME KNEE AND TOLD HIM THAT A PIECE FELL APART. HE WANTS TO LET SOMEONE KNOW THAT HIS FIRST KNEE REPLACEMENT WAS A FAILURE. ADDITIONAL INFORMATION RECEIVED DATED SEP 16, 2024: ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS REVISED ON (B)(6) 2023 TO ADDRESS PAIN AND LIMITED MOBILITY AS WELL AS POSSIBLE INFECTION. PATIENT STATED THAT ONE OF THE PIECES "BROKE OFF", BUT WAS NOT CERTAIN WHICH PIECE BROKE. DEPUY COMPONENTS WERE REMOVED AND DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT KNEE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Joint Contracture; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 20279531 ↗
• InjuryJun 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT TOTAL KNEE TO ADDRESS PATELLA DISASSOCIATION. DATE OF IMPLANTATION: (B)(6) 2012. DATE OF REVISION: (B)(6) 2020; (LEFT KNEE). TREATMENT: REVISION OF PATELLA AND TIBIAL INSERT COMPONENTS.

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

  MAUDE report 11957746 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 11596532 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRIMARY LCS TOTAL KNEE REPLACEMENT ON THE (B)(6) 2007. HAS BEEN COMPLAINING ABOUT INCREASING KNEE PAIN OVER THE LAST 12-18 MONTHS. THE DECISION WAS MADE TO REVISE THE KNEE. WHEN THE KNEE WAS OPENED, THERE WAS SIGNIFICANT METAPLASIS NOTED IN THE SOFT TISSUES SURROUNDING THE KNEE, AS WELL AS SIGNIFICANT SCRATCH MARKS ON THE FEMORAL AND TIBIAL COMPONENT ARTICULATING SURFACES, THERE WAS ALSO SIGNIFICANT PITTING AND DELAMINATION NOTED TO THE POLYETHYLENE INSERT. THE SURGEON COMMENTED THAT HE THOUGHT THIS COULD BE A SUSPECTED CASE OF THIRD BODY WEAR. THE REMOVED IMPLANTS WERE SENT TO (B)(6) BIO-ENGINEERING FOR EVALUATION AS PER THE STANDARD (B)(6) PROTOCOL.

  Patient problems: Inflammation; No Code Available; Pain

  MAUDE report 9565190 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO PUBLIC HOSPITAL WITH PUS/BOIL WOUND ON RIGHT KNEE - WHERE SCAR FROM TKR WAS. BLOODS DONE AND ELEVATED IN INFECTION MARKERS - WASHOUT DECIDED UPON + POLY CHANGE. DURING SURGERY IT WAS DISCOVERED THAT THE PUS AREA TRACKED DOWN INTO THE PROXIMAL TIBIA SO THE DECISION WAS MADE TO DO A FIRST STAGE REVISION AND REMOVE ALL IMPLANTS. INFECTION TO BE TREATED AND THEN A 2ND STAGE REVISION TKR TO BE PERFORMED IN 6-8 WEEKS.

  Patient problems: Adhesion(s); No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9322267 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE KNEE WAS REVISED ON THE 16.7.2015 (B)(4) WHERE THE FEMUR AND INSERT WE REPLACED WITH A LG LCS MODULAR REVISION FEMUR WITH A 115MM STEM AND NEW LG INSERT. THE PATELLA WAS ALSO RESURFACED WITH A METAL BACKED PATELLA (NO IMPLANT DETAILS AVAILABLE). PATIENT REPORTED INCREASING ANTERIOR KNEE PAIN. UPON REVISION THE FEMUR AND TIBIA WERE WELL FOUND TO BE WELL FIXED AND NO VISIBLE WEAR ON THE INSERT WITH ALL 3 COMPONENTS BEING RETAINED. THE PATELLA COMPONENT WAS REMOVED WITH A FAIR AMOUNT OF WORK HOWEVER CAME OFF WITH A LITTLE FIBROUS IN-GROWTH AND VERY LITTLE BONE. A CEMENTED PATELLA COMPONENT WAS REINSERTED INTO THE KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8682339 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED KNEE. REMOVAL OF ALL IMPLANTS. NO EXTRA SURGICAL TIME NEEDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8550946 ↗
• 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 8146277 ↗
• InjuryOct 4, 2018Naturally Worn; Naturally Worn

  PATIENT HAD WEAR AND OSTEOLYSIS EVIDENT ON X-RAYS 10 YEARS POST PRIMARY TKR - (B)(6) 2008. DURING SURGERY METALLOSIS WAS EVIDENT AND SIGNIFICANT POLYETHYLENE WEAR ON BOTH SIDE OF TIBIAL INSERT.

  Patient problems: Not Applicable; Osteolysis; Pain; Swelling; Tissue Damage

  MAUDE report 7934129 ↗
• InjuryMay 10, 2018Fracture; Fracture

  PRIMARY IMPLANT DATE: (B)(6) 2006. REVISION (B)(6) 2018 FOR: BROKEN PATELLA POLYETHYLENE LINER. PATIENT PRESENTED TO SURGEON WITH KNEE PAIN. ON X-RAY INVESTIGATION IT WAS NOTED THAT THE POLYETHYLENE PATELLA WAS DISASSOCIATED FROM THE METAL BACK PATELLA BASE. A REVISION OF THE PATELLA IMPLANT WAS PERFORMED. THE POLYETHYLENE PATELLA LINER WAS NOTED TO BE BROKEN INTO 2 PIECES. THE METAL BACK PATELLA WAS THEN REMOVED FROM THE PATELLA BONE AND A ALL POLLY PATELLA WAS THEN INSERTED AND THE KNEE WOUND CLOSED.

  Patient problems: Not Applicable; Pain

  MAUDE report 7502506 ↗