SIGMA 2024-56-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295083290), received between Nov 19, 2018 and Jan 6, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION THE T HANDLES ARE BOTH CRACKED AND FEMORAL INTRODUCER IS SNAPPED IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078663 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT THE FEMORAL HOLDER SNAPPED INTRAOPERATIVELY ON NOVEMBER 6, 2024. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20686904 ↗
• MalfunctionOct 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE FEMORAL INTRODUCER BROKE. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396906 ↗
• MalfunctionApr 2, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  SPRING LOOSE DUE TO LONG TERM USE, DOES NOT GRASP THE COMPONENT VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027463 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT THE PRODUCT BROKE IN 2 PARTS DURING THE IMPACTION OF THE FEMUR. FOR THE OTHER PRODUCT: THE SCREW OF THE BRACELET BROKE IN THE SCREW THREAD. IT WAS IMPOSSIBLE TO DISASSEMBLE IT FOR USE. THE IMPACTED PRODUCTS WERE IN CONTACT WITH THE PATIENT. NO PATIENT CONSEQUENCE. NOTHING TO REPORT REGARDING THE ACTUAL STATE OF THE PATIENT. THE SURGICAL TECHNICAL HAD BEEN CHANGED: MANUAL IMPLANTATION, SO LESS PRECISE MANAGEMENT OF POSITIONING AND ROTATION. SURGICAL DELAY OF 15 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18749645 ↗
• MalfunctionApr 4, 2023Break; Break

  IT WAS REPORTED THE IMPACTOR BROKE ON IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674723 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION OF A SIGMA PARTIAL UNICOMPARTMENTAL FEMORAL COMPONENT, A PIECE OF THE IMPACTOR HANDLE BROKE OFF. ALL BROKEN FRAGMENTS WERE REMOVED AND THE COMPONENT WAS SUCCESSFULLY IMPLANTED USING THE CYLINDRICAL IMPACTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965800 ↗
• MalfunctionJun 2, 2021Unintended Movement; Unintended Movement

  THE FEMORAL INTRODUCER IS QUITE LOOSE AND THE FEMUR IMPLANT MOVES AROUND WHEN IN THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924763 ↗
• MalfunctionJan 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HP UNI FEMORAL TRIAL HOLDER WILL NOT ENGAGE WITH THE FEMORAL TRIAL FOR EXTRACTION. SURGEON REQUEST A REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11120703 ↗
• MalfunctionDec 9, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  AS THE SCRUB TECH TRIED TO LOAD THE HP SIGMA UNI FEMUR TRIAL ON THE FEMORAL INSERTER, THE SPRING BROKE AND THE FEMUR COULD NOT BE LOADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979050 ↗
• MalfunctionFeb 25, 2019Break; Crack; Break; Crack

  INTRAOPERATIVELY THE INSTRUMENT FISSURED. NO SURGERY DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8366723 ↗
• MalfunctionJan 14, 2019Break; Break

  IT WAS REPORTED THAT AS THEY WERE USING THE UNI FEMORAL INTRODUCER TO INSERT ONE OF THE UNI FEMORAL TRIALS THE DEVICE BROKE IN TWO. THE INNER PLASTIC SHAFT OF THE DEVICE EXPERIENCED A CLEAN BREAK IN THE PROXIMAL UPPER THIRD OF THE INSTRUMENT, RESULTING IN THE INNER SPRING RELEASING ITS TENSION AND FORCING THE RED BUTTON ACTUATOR ON THE TOP OF THE DEVICE TO SEPARATE FROM THE BODY OF THE INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8244212 ↗
• MalfunctionNov 19, 2018Crack; Crack

  IT WAS REPORTED THAT THE FEMORAL INSERTER CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8086365 ↗