NA 75100857Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07611996121902), received between Dec 28, 2020 and Apr 6, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) TRIAL FEMORAL HEAD 36 M+4 BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690802 ↗
• MalfunctionDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE INSIDE OF A TRIAL FEMORAL HEAD 36 M/+4 BROKE. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACKUP DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048325 ↗
• InjuryOct 28, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A PIECE OF A TRIAL FEMORAL HEAD 36 M/+4 BROKE OFF WHEN THE SURGEON WAS PERFORMING A TRIAL REDUCTION OF THE HIP. THE BROKEN PIECE OF PLASTIC WAS RETRIEVED FROM THE PATIENT'S WOUND. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712276 ↗
• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE TRIAL FEMORAL HEAD 36 M/+4 BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544924 ↗
• MalfunctionSep 10, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING A THR THAT A TRIAL FEMORAL HEAD 36 M/+4 BROKE. NO PIECES FELL INTO PATIENT, PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452570 ↗
• MalfunctionAug 3, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA A TRIAL FEMORAL HEAD 36 M/+4 WAS BROKEN. SURGERY WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE, WITHOUT ANY SURGICAL DELAY. PATIENT WAS NOT INJURES AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267515 ↗
• MalfunctionApr 13, 2021Break; Break

  IT WAS REPORTED THAT THE TRIAL BROKE DURING SURGERY, WHILE OUTSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11654379 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER PROCEDURE, STAFF NOTICED THAT ONE OF THE TABS ON THE TRIAL HEAD WAS BENT. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620378 ↗
• MalfunctionJan 7, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS NOTICED THAT, DURING THE SURGERY, THE HEAD TRIAL WOULD BECOME EASILY DISASSOCIATED FROM THE TRIAL STEM WHILE TRIALING. UPON INSPECTION FOLLOWING THE SURGERY, IT WAS NOTICED THAT THE TRIAL IS FRACTURED AT THE STEM TAPER LOCKING REGION. THE PROCEDURE HAD BEEN COMPLETED USING THE SAME DEVICE. A SURGICAL DELAY OF 30 MIN OR LESS WAS REPORTED. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11133868 ↗
• MalfunctionDec 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING AN EFIP INSPECTION THE INNER CLIP OF THE TRIAL FEMORAL HEAD 36 M/+4 WAS FOUND BROKEN. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11085362 ↗