NA 2140-00-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295091653), received between Jul 23, 2021 and Jun 10, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2025Break; Illegible Information; Break; Illegible Information

  IT WAS REPORTED THAT THE HANDLE ON TWO DISLOCATION LEVERS BROKE IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178152 ↗
• MalfunctionJun 10, 2025Break; Break

  IT WAS REPORTED THAT THE HANDLE ON TWO DISLOCATION LEVERS BROKE IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178124 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT HIP SKID BROKE IN HALF. THERE WAS NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21857374 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT THE LARGE COBB WAS BROKEN WHEN REMOVING THE FEMORAL HEAD. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21701802 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE IN HALF. THERE WAS NO SURGICAL DELAY OR NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151383 ↗
• MalfunctionJan 14, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE EMPHASIS CUP WAS LOOSE ON THREADS. THIS IS FOR THE EMPHASIS MANUAL CUP IMPACTOR. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150432 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT THE HANDLE BROKE IN HALF.

  Patient problems: Insufficient Information

  MAUDE report 19114658 ↗
• MalfunctionJan 2, 2024Break; Break

  IT WAS REPORTED THAT TWO TOTAL HIP INSTRUMENTS BROKE DURING THE CASE. BACKUPS WERE AVAILABLE SO THERE WAS NO DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432809 ↗
• MalfunctionSep 21, 2023Break; Break

  DURING A HEMI HIP ARTHROPLASTY CASE, THE SURGEON WAS USING THE DISLOCATION LEVER AND THE HANDLE BROKE DURING THE CASE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792811 ↗
• MalfunctionMar 1, 2023Break; Break

  IT WAS REPORTED THAT DURING TOTAL HIP SURGERY, ONE INSTRUMENT BROKE DURING THE CASE. THERE WAS NO SURGICAL DELAY BECAUSE THEY HAD A BACKUP AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459993 ↗
• MalfunctionJul 23, 2021Break; Break

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, ONE INSTRUMENT BROKE. THERE WERE BACKUP INSTRUMENTS AVAILABLE, AND THERE WERE NO PROBLEMS OR DELAYS IN SURGERY BECAUSE OF THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218542 ↗