SIGMA 9505-01-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295224815), received between Jan 23, 2018 and Feb 22, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED THE IMPACTORS ARE DAMAGED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420299 ↗
• MalfunctionFeb 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE RATCHET MECHANISM IS NO LONGER WORKING. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16408993 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT THE PATELLA RESECTION CLAMP WON'T STAY CLAMPED. TEETH ARE WORN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833554 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CUTTER CLASP WILL NOT HOLD. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305438 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CUTTER CLASP WILL NOT HOLD. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305435 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CUTTER CLASP WILL NOT HOLD. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305434 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CUTTER CLASP WILL NOT HOLD. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305430 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CUTTER CLASP WILL NOT HOLD. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305427 ↗
• MalfunctionFeb 9, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT PATELLA CUTTER CLASP WILL NOT HOLD. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11305426 ↗
• MalfunctionFeb 13, 2020Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT THE DEPTH PADDLE BROKE OFF OF THE SIGMA PATELLA CUTTING GUIDE. THE PIECE WENT MISSING IN THE WASHER STERILIZER. THE CLAMP IS BEING RETURNED WITHOUT THE BROKEN PIECE. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9709914 ↗
• MalfunctionJan 23, 2020Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn

  IT WAS REPORTED THAT DURING TKA WITH SIGMA HP INSTRUMENTS THE DOCTOR STATED THAT THE PATELLA CLAMP WAS WORN AND NOT HOLDING. ANOTHER SET WAS OPENED AND THE DOCTOR FELT THAT THE CLAMP WAS ALSO LOOSE. BOTH NEED TO BE REPLACED DUE TO WEAR.

  Patient problems: Not Applicable

  MAUDE report 9622235 ↗
• MalfunctionDec 20, 2019Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS USING THE PATELLA RESECTION GUIDE TO CUT THE PATELLA, BUT IT KEPT UNLOCKING CAUSING THE DOCTOR TO READ JUST THE INSTRUMENT. THERE WASN¿T ANY SIGNIFICANT DELAY TO THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505813 ↗
• MalfunctionMay 29, 2019Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING TKA, THE PATELLA CLAMP WAS NOT CATCHING TO HOLD THE PATELLA FOR A RESECTION CUT.

  Patient problems: Not Applicable

  MAUDE report 8649485 ↗
• MalfunctionMar 28, 2019Difficult to Insert; Positioning Problem; Difficult to Insert; Positioning Problem

  (B)(4). SIGMA HP PAT RES GUIDE - NOT WORKING. THIS WAS DISCOVERED TO BE FAULTY DURING A CASE YESTERDAY. THE SURGERY WAS NOT SLOWED DOWN AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460813 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED THAT THE PATELLA RESECTION DEVICE WHICH IS THE CLAW FROM SIGMA SNAPS OPEN AFTER BEING CLAMPED ON PATELLA. THIS HAPPEN AS SOON AS THE SAW VIBRATES IT.

  Patient problems: Not Applicable

  MAUDE report 8456290 ↗
• MalfunctionFeb 5, 2018Break; Break

  IT WAS REPORTED THAT THE PATELLA CLAMP TIP BROKE IN THE RATCHET MECHANISM. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7240869 ↗
• MalfunctionJan 23, 2018Break; Break

  IT WAS REPORTED THAT THE PATELLA CUTTING GUIDE HAD PIECE BREAK OFF IN THE RATCHET MECHANISM AND ALL PIECES WERE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211816 ↗