SIGMA HIGH PERFORMANCE 9505-01-234Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295225393), received between Oct 13, 2017 and Oct 24, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PIECES WERE NOT FITTING TOGETHER. THE EVENT DID NOT OCCUR IN A PROCEDURE. THERE WAS NO SURGEON INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378417 ↗
• MalfunctionMar 21, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA FOR THE LEFT KNEE JOINT WITH THE PRODUCT IN QUESTION. DURING SURGERY, THE STEINMANN PIN WAS STUCK IN THE DISTAL TEMPORARY FIXATION MEDIAL PIN HOLE OF THE PRODUCT IN QUESTION AND COULD NOT BE PULLED OUT. HOWEVER, THE SURGERY WAS PERFORMED AS IT WAS, AND THE PROCEDURE WAS NOT AFFECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18949682 ↗
• MalfunctionNov 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT 2 PIECES OF THE DISTAL FEMORAL CUTTING JIG HAVE BECOME STUCK AND WONT DISENGAGE EACH OTHER. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15805848 ↗
• MalfunctionJan 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  RESECTION DIAL GUIDE WOULD NOT SLIDE FREELY ON RESECTION ALIGNMENT GUIDE OUTRIGGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196681 ↗
• MalfunctionAug 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE LEVER OF THE DEVICE WAS STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378463 ↗
• MalfunctionMay 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  WHEN ATTACHING TO RESECTION GUIDE ON TO THE TWO POSTS OF THE ALIGNMENT GUIDE THE GUIDE IS UNABLE TO SLIDE UP AND DOWN ON THE TWO POSTS. IT BECOMES STUCK AT THE BASE OF THE TWO POSTS AND HAD TO BE PRIED APART WITH A COBB. NO NOTICEABLE BURRS OR BENT POSTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797069 ↗
• MalfunctionMar 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  NEW INSTRUMENTS, BUT THE RESECTION GUIDE DOES NOT FIR LIKE IT SHOULD INTO THE ALIGNMENT GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476167 ↗
• MalfunctionAug 31, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  DISTAL CUTTING JIG WAS JAMMED AND WAS UNABLE TO BE LOOSENED TO ALLOW FOR THE CORRECT SIDE OR VERSION SET FOR THE FEMORAL DISTAL CUT. LUCKILY WE HAD A PRIMARY KNEE KIT AVAILABLE TO OPEN TO GET ANOTHER JIG SET UP TO MAKE THE CASE RUN SMOOTHLY.

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

  MAUDE report 10471927 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED THAT THE DISTAL FEMORAL ALIGNMENT GUIDE BLUE TOGGLE SWITCH BROKE OFF DURING SURGERY. IT WAS RETRIEVED AND WAS DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420170 ↗
• MalfunctionJan 25, 2019Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  PORTION OF FEMORAL CUTTING GUIDE IS WORN AND DOESN¿T HOLD GUIDE TOGETHER AND THE PIECE DROPPED ON THE FLOOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276913 ↗
• MalfunctionAug 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DISTAL FEMORAL CUTTING JIG WOULD NOT ASSEMBLE PROPERLY. TWO PIECES GOT JAMMED TOGETHER. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801440 ↗
• MalfunctionOct 13, 2017Mechanical Problem; Mechanical Problem

  DER STATES THAT WHEN SETTING UP INSTRUMENTS IT WAS DISCOVERED THE DISTAL FEMORAL ALIGNMENT GUIDE WOULD NOT ACCEPT THE DIAL PIECE. IT WAS ALSO STATED THAT THEY OPENED ANOTHER TRAY TO FIGURE OUT WHICH PIECE WAS DEFECTIVE. THE FIRST WORKED WITH OTHER ALIGNMENT GUIDES.

  Patient problems: No Information

  MAUDE report 6947741 ↗