LCS 2267-77-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295108948), received between Oct 13, 2017 and Oct 7, 2024 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT LCS IMPACTORS ARE WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385487 ↗
• MalfunctionOct 7, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT LCS IMPACTORS ARE WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385482 ↗
• MalfunctionOct 7, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT LCS IMPACTORS ARE WORN OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385476 ↗
• MalfunctionOct 2, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  HP FEMORAL IMPACTOR SPRING IS BROKEN. A DIFFERENT TRAY WAS OPENED. PROCEDURE SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850548 ↗
• MalfunctionDec 10, 2021Crack; Crack

  IT WAS REPORTED THAT THE INSTRUMENT WAS CRACK IN METAL HANDLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974782 ↗
• MalfunctionJun 3, 2019Material Deformation; Scratched Material; Material Deformation; Scratched Material

  LCS FEMORAL IMPACTOR DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8662542 ↗
• MalfunctionMar 7, 2019Device Damaged Prior to Use; Naturally Worn; Scratched Material; Device Damaged Prior to Use; Naturally Worn; Scratched Material

  INSTRUMENTS WERE FLAGGED DURING STERILISATION PROCESS. NO ADVERSE EVENTS REPORTED. THE IMPACTING SURFACE AND SIDES OF THE FEMORAL IMPACTOR HAVE BEEN SCRATCHED AND DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8400424 ↗
• MalfunctionJan 16, 2019Scratched Material; Scratched Material

  IMPACTOR BECAME SCUFFED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252238 ↗
• MalfunctionDec 3, 2018Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE WHILE IMPLANTING THE FEMUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8125018 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR WAS USED FOR SIGMA KNEES AND IT IS LEAVING BLACK RESIDUE ON THE FEMUR TRIAL WHICH GET INTO THE PATIENT. IT NEEDS TO BE REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7709781 ↗
• MalfunctionJun 14, 2018Break; Break

  IT WAS REPORTED THAT THE PLASTIC ON THE IMPACTOR CHIPPED OFF. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600775 ↗
• MalfunctionMay 23, 2018Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR HAS A LARGE PIECES OF PLASTIC THAT SCRATCHED OFF. THE IMPACTOR HEAD IS SEVERLY SCRATCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7536898 ↗
• MalfunctionMar 23, 2018Fracture; Fracture

  FRACTURE OF INSTRUMENT INTO TWO OR MORE PARTS. NO SURGERY PROLONGATION REPORTED, NO ADVERSE CONSEQUENCES FOR PATIENT REPORTED, NO PART REMAINING IN PATIENT BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366262 ↗
• MalfunctionDec 18, 2017Scratched Material; Scratched Material

  (B)(6) - REPORTED TO (B)(4) REP BY CSD STAFF. DEEP GOUGES FOUND BY CSD STAFF ON SURFACE OF LCS FEMORAL IMPACTOR. DEEP CHIPS ON FEMORAL TRIAL SURFACE. NOT LINKED TO A SPECIFIC PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125408 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE BLACK PLASTIC IS BROKEN OFF. NO PART REMAINING IN PATIENT. NO SURGERY PROLONGATION, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121201 ↗
• MalfunctionDec 15, 2017Break; Break

  IT WAS REPORTED THAT THE BLACK PLASTIC IS BROKEN OFF. NO PART REMAINING IN PATIENT. NO SURGERY PROLONGATION, NO ADVERSE CONSEQUENCES FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7121165 ↗
• MalfunctionOct 13, 2017Break; Break

  IT WAS REPORTED THAT THE FEMORAL IMPACTOR BROKE DURING CASE.

  Patient problems: No Information

  MAUDE report 6948464 ↗