SIGMA LCS 9505-01-305Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10603295226031), received between Jul 7, 2017 and Jun 12, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Break” (56 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE IMPACTOR DEVICES WERE BROKEN DURING THE CASE. IT WAS REPORTED THAT ALL PARTS WERE REMOVED FROM STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491090 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT WHEN IMPACTING AND SECONDARY IMPACTING THE RED KNOB BROKE OFF THE INTRODUCER AND THE SPRING IN THE SIGMA UNIVERSAL HANDLE BROKE. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446478 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, WHEN SECONDARY IMPACTING THE FEMORAL COMPONENT, THE SIGMA UNIVERSAL HANDLE WAS BROKEN. IT WAS REPORTED THAT ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397550 ↗
• MalfunctionDec 15, 2025Break; Break

  UNIVERSAL HANDLE BROKE INTO THREE PIECES PATIENT STATUS/ OUTCOME / CONSEQUENCES NO PATIENT INVOLVEMENT, 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)(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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810322 ↗
• MalfunctionNov 4, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN INITIALLY IMPACTING THE FEMUR IMPLANT, THE RED KNOB BROKE OFF THE INTRODUCER. IT WAS REPORTED THAT THE SIGMA IMPACTOR UNIVERSAL HANDLE INSIDE BROKE AND WOULD NOT HOLD THE IMPACTOR TIP ON. ALL PIECES WERE REMOVED, AND NO HARM WAS DONE TO THE PATIENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472520 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT WHEN IMPACTING FEMURS, THE SIGMA IMPACTOR HANDLE BROKE INTO TWO OR MORE PIECES. ALL PIECES WERE REMOVED AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401806 ↗
• MalfunctionMay 30, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT UNIVERSAL HANDLE HAD A PIN COMING LOOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114224 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE TIP OF THE UNIVERSAL HANDLE HAS SNAPPED OFF AND THE PINK LEVER DOESN'T WORK FOR THE DRILL CLAMP. THE PRODUCT DAMAGE HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004540 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT THE RED KNOB BROKE OFF OF INTRODUCER AND CONNECTING PLATE ON SIGMA HANDLE BROKE OFF. THE SURGICAL DELAY IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996964 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE REPLACEMENT. THE AIGMA IMPACTOR BROKE AT CONNECTION POINT. ALL PIECES WERE RETRIEVED AND NO HARM WAS DONE TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081847 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT THE SIGMA IMPACTION HANDLE CONNECTION POINT BROKE ON BOTH HANDLES. FEM INTRODUCER KNOB BROKE OFF. NO HARM WAS DONE TO PATIENT AND ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080704 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT THE SIGMA IMPACTION HANDLE CONNECTION POINT BROKE ON BOTH HANDLES. FEM INTRODUCER KNOB BROKE OFF. NO HARM WAS DONE TO PATIENT AND ALL PIECES RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080672 ↗
• MalfunctionJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE FEMORAL IMPACTOR AND HANDLE HAVE FUSED TOGETHER AND COULD NOT BE PULLED APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643836 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT THE IMPACTOR TIP BROKE AT CONNECTION POINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19620139 ↗
• MalfunctionApr 16, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SIGMA IMPACTION HANDLE STUCK.

  Patient problems: Insufficient Information

  MAUDE report 19118241 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT SIGMA IMPACTION HANDLE INTERNAL SPRING BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093982 ↗
• MalfunctionJan 8, 2024Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE KNOB OF THE INSTRUMENT HAS SNAPPED OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN.  THE EVENT DATE  AND  ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE.  THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466787 ↗
• MalfunctionJan 8, 2024Break; Device-Device Incompatibility; Naturally Worn; Break; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT DURING SURGERY AN INTERNAL PART IN A SIGMA UNIVERSAL HANDLE BROKE OR WORE OUT. THE HANDLE WILL NO LONGER HOLD THE FEMUR OR TIBIA IMPACTOR TIPS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18466505 ↗
• MalfunctionDec 27, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE SIGMA IMPACTION HANDLE SPRING NO LONGER WORKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18402910 ↗
• MalfunctionDec 4, 2023Break; Break

  IT WAS REPORTED THAT UNIVERSAL HANDLE PIN HAS BROKEN AND THE FEMORAL IMPACTOR IS STUCK IN PLACE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18263782 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT THE HP UNIVERSAL HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17618330 ↗
• MalfunctionAug 24, 2023Break; Break

  IT WAS REPORTED THAT THE HP UNIVERSAL HANDLE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617871 ↗
• MalfunctionJul 20, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES PORTUGAL REPORTS AN EVENT AS FOLLOWS: LOAN ORTHOKIT ARRIVED TO LOCAL DC WITH A BROKEN TIP. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17361443 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT IMPACT IS CRACKED. HANDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278174 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT IMPACTS IS CRACKED. HANDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278155 ↗