SIGMA LCS HIGH PERFORMANCERecalls & reported problems across all models

We found 8 models of SIGMA LCS HIGH PERFORMANCE by Depuy Orthopaedics, Inc. in the FDA's device registry (GUDID). Together they are named in 138 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Nov 14, 2025 — classified as 2 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Break” (85 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SIGMA LCS HIGH PERFORMANCE problems

SIGMA LCS HIGH PERFORMANCE models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SIGMA LCS HIGH PERFORMANCE 9505-02-012

  PUNCH, SURGICAL
  85 reports
• SIGMA LCS HIGH PERFORMANCE 9505-02-011

  PUNCH, SURGICAL
  30 reports
• SIGMA LCS HIGH PERFORMANCE 9505-02-303

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  9 reports
• SIGMA LCS HIGH PERFORMANCE 9505-02-015

  PUNCH, SURGICAL
  8 reports
• SIGMA LCS HIGH PERFORMANCE 9505-02-014

  PUNCH, SURGICAL
  3 reports
• SIGMA LCS HIGH PERFORMANCE 9505-02-022

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• SIGMA LCS HIGH PERFORMANCE 9505-02-023

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• SIGMA LCS HIGH PERFORMANCE 9505-02-034

  INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
  1 report

Recent SIGMA LCS HIGH PERFORMANCE adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJun 5, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT SPIKED KEEL PUNCH WAS BROKEN WHERE IT CONNECTS TO THE INSERTER HANDLE. SO IT DID NOT STAY ON THE INSERTER IN ORDER TO IMPACT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060782 ↗
• 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 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951475 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951470 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951408 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951265 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED THAT YESTERDAY, WHILE COVERING ONE OF THE SURGEON'S SIGMA KNEE REPLACEMENT CASES, HIS PHYSICIAN ASSISTANT ASKED THE REP WHAT IT WOULD TAKE TO REPLACEMENT SOME OF THE KEEL PUNCHES IN THEIR HOSPITAL'S CONSIGNMENT INSTRUMENTATION TRAYS. SHE THEN SHOWED THE REP HOW ONE OR BOTH OF THE SMALL METAL TINES ON THE CONNECTION END OF THE KEEL PUNCH THEY WERE ABOUT TO USE WERE MISSING. SHE EXPLAINED THAT THE PUNCHES CAN STILL BE USED, EVEN WITHOUT THE MISSING TINES, BUT THEY DON'T FIT AS SECURELY ON THE IMPACTION HANDLES WITHOUT THE MISSING TINES. SALES REP EXPLAINED OUR COMPANY'S DEVICE REPORTING SYSTEM AND INSTRUMENTATION REPLACEMENT PROCESS AND THEN PROCEEDED TO INSPECT ALL OF THE KEEL PUNCHES IN THE HOSPITAL'S CONSIGNMENT TRAYS UPON THE COMPLETION OF OUR CASE. A TOTAL OF FIVE PUNCHES WERE FOUND WITH BROKEN TINES. IT IS UNKNOWN WHEN AND WHERE THE TINES BROKE OFF. THE BROKEN PUNCH NEEDED IN THE SURGEON'S CURRENT CASE WAS USED WITHOUT INCIDENCE, SINCE AN IMMEDIATE REPLACEMENT WAS UNAVAILABLE. THE SURGICAL TIME OF THE CASE WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951252 ↗
• MalfunctionOct 3, 2022Break; Break

  IT WAS REPORTED THAT THE CONNECTION FOR HANDLE ATTACHMENT IS BROKEN OFF ON BOTH ITEMS. NO LOOSE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527360 ↗
• MalfunctionSep 28, 2022Break; Break

  IT WAS REPORTED THAT THE CONNECTION FOR HANDLE ATTACHMENT IS BROKEN OFF ON BOTH ITEMS. NO LOOSE ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496223 ↗
• MalfunctionSep 28, 2022Break; Break

  IT WAS REPORTED THAT THE CONNECTION FOR HANDLE ATTACHMENT IS BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496039 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT THE HP MBT CEM KEEL PUNCH SZ 4-7 HAS A BROKEN CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632578 ↗
• MalfunctionApr 22, 2022Break; Failure to Cut; Break; Failure to Cut

  IT WAS REPORTED THAT DEVICE WAS BROKEN AND DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189261 ↗

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