SIGMA LCS HIGH PERFORMANCE 9505-02-303Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295228912), received between Jun 22, 2017 and Nov 14, 2025 — classified as 2 injuries, 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2025Break; Break

  IT WAS REPORTED THAT THE THREADED HEADED PIN SNAPPED INTO TWO PIECES WHEN INSERTING IT UNDER POWER INTO THE FEMORAL SIZER WITH THE PIN DRIVER. THERE WAS NO PATIENT HARM OR ADVERSE EVENT THAT OCCURRED AS A RESULT OF THIS INCIDENT, NOR WAS THERE A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559952 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENTS RECEIVED FOR IT BAND TENDINITIS. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: POSSIBLY. DATE OF EVENT: 26/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT. DEPUY SYNTHES PRODUCT USED: CATALOG ID: 151820032, LOT ID: 3802592, COMPONENT TYPE: PATELLAR, DESCRIPTION: ATTUNE MEDIAL DOME PAT 32MM; CATALOG ID: 151820308, LOT ID: JP9042, COMPONENT TYPE: INSERT, DESCRIPTION: ATTUNE LEFT MEDIAL STABILIZED INSERT SIZE 3 8MM; CATALOG ID: 150400103, LOT ID: 8093073, COMPONENT TYPE: FEMORAL, DESCRIPTION: ATTUNE C/RET FEM LT SZ 3 CEMENTED; CATALOG ID: 150670003, LOT ID: 9854210, COMPONENT TYPE: TIBIAL, DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 3; CATALOG ID: 249095000, LOT ID: M0476R, COMPONENT TYPE: PIN, DESCRIPTION: AMK FIXATION PINS 1/8 DIA X 3; CATALOG ID: 950502303, LOT ID: M1312Z, COMPONENT TYPE: ACC, DESCRIPTION: SIGMA LCS HIGH PERFORMANCE, STERILE THREADED HEADED PINS; CATALOG ID: 3312040, LOT ID: 3807417, COMPONENT TYPE: CEMENT, DESCRIPTION: SMART SET CMW 1 40G.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20904074 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (LEFT KNEE) TREATMENT: ASPIRATION.

  Patient problems: Unspecified Infection

  MAUDE report 19342402 ↗
• MalfunctionMar 31, 2023Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE HEAD OF A THREADED PIN WAS SHEARED OFF WHILE IN THE A CHAMFER CUT BLOCK. UNABLE TO REMOVE PIN FROM BLOCK. NO PIECES BROKE OFF OR WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16654267 ↗
• MalfunctionJul 22, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HEADED PIN BECAME STUCK IN SIZE 3 REVISION CUT BLOCK. ALL PIECES WERE RETRIEVED AND THE SURGERY WAS NOT DELAYED. RETURNING BLOCK WITH PIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811811 ↗
• MalfunctionDec 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PINS GOT STUCK IN UNI TIBIAL CUTTING GUIDE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7134106 ↗
• MalfunctionDec 20, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PINS GOT STUCK IN UNI TIBIAL CUTTING GUIDE. NO SURGICAL DELAY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7134046 ↗
• MalfunctionJul 18, 2017Bent; Bent

  IT WAS REPORTED THAT THE SURGEON TRIED TO REMOVE HEADED PIN FROM THE TIBIA CUTTING GUIDE AND IT GOT STUCK, WHICH IT CAUSED TO BEND.

  Patient problems: No Information

  MAUDE report 6721852 ↗
• MalfunctionJun 22, 2017Break; Break

  IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO DRILL HEADED PIN THROUGH PIN HOLE ON THE LEFT MEDIAL PROXIMAL TIBIA CUTTING GUIDE. PIN SPUN AND GOT STUCK CAUSING THE TIP TO BREAK OFF INSIDE THE PIN DRIVER. A SECOND PIN DRIVER WAS USED FOR THE REMAINDER OF THE CASE.

  Patient problems: No Information

  MAUDE report 6659598 ↗