LCS COMPLETE 1294-09-550Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295022589), received between Sep 28, 2017 and Dec 8, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A LCS KNEE SOME TIME AGO (NO DETAILS AVAILABLE OF INITIAL OPERATION. BEING REVISED TO A 1ST STAGE SPACER FOR INFECTION. NO FURTHER DETAILS AVAILABLE. IF OTHER, DESCRIBE INFECTION., IF OTHER, DESCRIBE 1ST STAGE REVISION TO TEMPORARY SPACER - INFECTION, 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, OTHER INFORMATION N/A, 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, (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 ADDITI

  Patient problems: Unspecified Infection

  MAUDE report 15940161 ↗
• InjuryJun 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STD+ PATELLA WAS REMOVED FROM THE RIGHT KNEE BY SURGEON, AND REPLACED WITH A NEW STD+ PATELLA. THE PATIENT PRESENTED WITH THROBBING PAIN IN THE RIGHT KNEE, MOSTLY AROUND THE TIBIAL REGION. A BONE SCAN SHOWED AN INFLAMED PATELLA. INTRAOPERATIVELY, SURGEON REMOVED THE PATELLA COMPONENT, AND FOUND SEVERAL CYSTS IN THE PATELLA BONE. THE CYSTS WERE CLEARED OUT AND A NEW PATELLA IMPLANTED. SURGEON CHECKED THE FEMORAL, POLY AND TIBIAL COMPONENTS AND APART FROM SLIGHT WEAR ON THE POLYETHYLENE INSERT, DR DECIDED THESE A WERE OK TO LEAVE IN SITU.

  Patient problems: Cyst(s); Inflammation; No Code Available; Pain

  MAUDE report 10213045 ↗
• InjuryJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LCS STD+ PATELLA REMOVED BY DR (B)(6), AND REPLACED WITH A NEW STD+ PATELLA. ORIGINAL OPERATION CONDUCTED ON (B)(6) 2017 BY (B)(6) . 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: UNKNOWN. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(6). 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 (B)(4): TRUE.

  Patient problems: Edema; No Code Available

  MAUDE report 10195501 ↗
• 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 9954220 ↗
• InjuryAug 5, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  PRIMARY IMPLANTED ON (B)(6) 2012. REASON FOR REVISION: MALALIGNMENT. PATIENT HAD THE ABOVE IMPLANTS IN SITU. TKJR REVISION PERFORMED AS IMPLANTS MALALIGNED AND OSTEOLYSIS PRESENT. NO FURTHER COMMENT FROM SURGEON. IMPLANTS REMOVED, SPECIMENS TAKE TO RULE OUT INFECTION. J&J REP WAS PRESENT AT THE CASE. TC3 IMPLANTS IMPLANTED. IMPACTED PRODUCTS: 1 X D129424520; LCS COMP VVC INS STD+ 20MM; LOT NO: UNKNOWN; 1 X LCS STD + FEMUR -UNKNOWN JRN; 1 X D129435130C ; MBT REVISION CEM TIB TRAY SZ 3 ; LOT NO: FH8JL1; 1 X D11082083; UNKNWON JRN.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8861802 ↗
• InjurySep 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND PAIN.

  Patient problems: Osteolysis; Pain

  MAUDE report 6903168 ↗