SIGMA LCS HIGH PERFORMANCE 9505-02-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10603295227328), received between Oct 11, 2017 and Dec 9, 2022 — classified as 85 malfunctions.

The most frequently reported specific device problem is “Break” (57 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• 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 15951252 ↗
• 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 ↗
• 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 14189249 ↗
• 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 14189237 ↗
• MalfunctionApr 18, 2022Naturally Worn; Naturally Worn

  THE THREADS ARE WORN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138808 ↗
• MalfunctionApr 11, 2022Break; Break

  IT WAS REPORTED THAT THE CONNECTION TABS ARE BROKEN OFF ¿ A REPEATING PROBLEM REPORTED PREVIOUSLY ON THE ITEM. NO LOOSE PARTS. NO PARTS REMAINING IN PATIENT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074115 ↗
• MalfunctionApr 11, 2022Break; Break

  CONNECTION TOOTH ON HANDLE ATTACHMENT SITE HAS BROKEN OFF. PREVIOUSLY BEEN REPORTED. NO LOOSE ITEMS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073813 ↗
• MalfunctionApr 11, 2022Break; Break

  CONNECTION TOOTH ON HANDLE ATTACHMENT SITE HAS BROKEN OFF. PREVIOUSLY BEEN REPORTED. NO LOOSE ITEMS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073810 ↗
• MalfunctionApr 11, 2022Break; Break

  CONNECTION TOOTH ON HANDLE ATTACHMENT SITE HAS BROKEN OFF. PREVIOUSLY BEEN REPORTED. NO LOOSE ITEMS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073808 ↗
• MalfunctionApr 11, 2022Break; Break

  CONNECTION TOOTH ON HANDLE ATTACHMENT SITE HAS BROKEN OFF. PREVIOUSLY BEEN REPORTED. NO LOOSE ITEMS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073794 ↗
• MalfunctionApr 11, 2022Break; Break

  CONNECTION TOOTH ON HANDLE ATTACHMENT SITE HAS BROKEN OFF. PREVIOUSLY BEEN REPORTED. NO LOOSE ITEMS. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073787 ↗
• MalfunctionAug 17, 2021Break; Break

  IT WAS REPORTED THAT DURING THE IMPACTION OF THE TRIAL TIBIA, THE FEET THAT HOLD THE KEEL PUNCH TO THE INSERTED HANDLE SNAPPED. THERE WAS 30 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 12331807 ↗
• MalfunctionJul 12, 2021Break; Break

  IT WAS REPORTED THAT THE KEEL PUNCH BROKE AT ATTACHMENT SITE UPON IMPACTING THE INSTRUMENT INTO THE TIBIA. ALL PIECES WERE RECOVERED. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149473 ↗
• MalfunctionFeb 22, 2021Break; Break

  METAL BREAKAGE AT THE KEEL-PUNCH HANDLE ATTACHMENT SITE. IT WAS REPORTED TO BE BROKEN IN TWO PIECES. OCCURRED POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358487 ↗
• MalfunctionFeb 11, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED STATING THAT THEY HAVE SENT THE ITEMS TO WAREHOUSE FOR SHIPPING, BUT AS FAR AS THEY CAN RECALL, THE METAL TABS WAS BROKEN IN TWO PIECES AND THE BROKE-OFF ITEMS WHERE RETRIEVED AND INCLUDED IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313680 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS REMOVING THE PUNCH AFTER TRIALING AND THE HANDLE CAME OFF THE KEEL MULTIPLE TIMES. THE SURGEON EVENTUALLY GOT THE PUNCH OUT BUT IT APPEARS THAT THE PUNCH IS WORN OUT AND NOT ATTACHING TO THE KEEL HANDLE. NO PIECES BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 10943209 ↗
• MalfunctionOct 15, 2020Break; Break

  THE METAL TABS AT THE JUNCTION OF THE HANDLE ATTACHMENT HAVE BROKEN OFF. NO METAL PARTS LEFT IN THE WOUND/PATIENT ARE REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10683231 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS REMOVING THE TRIALS AND PART OF THE MBT PUNCH BROKE AS HE WAS TAKING IT OUT OF THE TIBIA. THE PIECE WAS FOUND AND IT DID NOT CAUSE A DELAY IN THE CASE. THE PUNCH WE WERE USING IS NO LONGER FUNCTIONAL AND IS BEING RETURNED. NO SURGICAL DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10538125 ↗
• MalfunctionAug 31, 2020Break; Break

  BROKEN METAL PIECE AT THE HANDLE ATTACHMENT SITE. ONE BROKEN PIECE ON BOTH PARTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474243 ↗
• MalfunctionAug 31, 2020Break; Break

  BROKEN METAL PIECE AT THE HANDLE ATTACHMENT SITE. ONE BROKEN PIECE ON BOTH PARTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474233 ↗