LCS COMPLETE 1294-27-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295025344), received between Mar 29, 2019 and Dec 5, 2019 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  HCP REPORTED TO (B)(6): "RELATIVE MOVEMENT OF THE FEMORAL SHIELD. THE EPIPHYSEAL ZONE IS LOOSENED AND THE PLUG CONE TO THE METAPHYSEAL SLEEVE SHOWS DISTINCT CORROSION MARKS (FRETTING). LOOSENING OF THE FEMORAL COMPONENT AFTER KNEE-TEP-CHANGE IN (B)(6) 2018. KNEE-TEP LCS REVISION ON (B)(6) 2019 - PARTIALLY COUPLED, STALK GUIDED, PARTIALLY CEMENTED."

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9416111 ↗
• InjuryDec 5, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  HCP REPORTED TO (B)(6): "RELATIVE MOVEMENT OF THE FEMORAL SHIELD. THE EPIPHYSEAL ZONE IS LOOSENED AND THE PLUG CONE TO THE METAPHYSEAL SLEEVE SHOWS DISTINCT CORROSION MARKS (FRETTING). LOOSENING OF THE FEMORAL COMPONENT AFTER KNEE-TEP-CHANGE IN (B)(6) 2018. KNEE-TEP LCS REVISION ON (B)(6) 2019: PARTIALLY COUPLED, STALK GUIDED, PARTIALLY CEMENTED."

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9416110 ↗
• InjuryDec 5, 2019Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  HCP REPORTED TO (B)(4): "RELATIVE MOVEMENT OF THE FEMORAL SHIELD. THE EPIPHYSEAL ZONE IS LOOSENED AND THE PLUG CONE TO THE METAPHYSEAL SLEEVE SHOWS DISTINCT CORROSION MARKS (FRETTING). LOOSENING OF THE FEMORAL COMPONENT AFTER KNEE-TEP-CHANGE IN (B)(6) 2018. KNEE-TEP LCS REVISION ON (B)(6) 2019; PARTIALLY COUPLED, STALK GUIDED, PARTIALLY CEMENTED."

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9416109 ↗
• MalfunctionApr 24, 2019Difficult to Insert; Difficult to Insert

  IT WAS IMPOSSIBLE TO ATTACH THE 5MM STD+ AUGMENT TO THE FEMORAL COMPONENT. THEY TRIED TO ATTACH A STD 5MM AUGMENT ALSO, BUT IT WAS IMPOSSIBLE TO GET IT ATTACHED TO THE FEMUR. THEY IMPLANTED THE FEMUR WITHOUT AUGMENT AND WITH EXTRA CEMENT. OPENED ANOTHER IMPLANT, BUT WAS ALSO IMPOSSIBLE TO ATTACH. 20 MINUTE DELAY.

  Patient problems: Not Applicable

  MAUDE report 8544087 ↗
• InjuryMar 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD A REVISION KNEE FOR ONGOING PAIN. MRI SHOWED AN INCREASED UPTAKE AROUND THE FEMUR-THIS WAS STATED IN THE NOTES AND CAN INDICATE LOOSENING OF THE COMPONENT.

  Patient problems: No Code Available; Pain

  MAUDE report 8463917 ↗
• InjuryMar 29, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD A REVISION KNEE FOR ONGOING PAIN. MRI SHOWED AN INCREASED UPTAKE AROUND THE FEMUR-THIS WAS STATED IN THE NOTES AND CAN INDICATE LOOSENING OF THE COMPONENT.

  Patient problems: No Code Available; Pain

  MAUDE report 8463903 ↗