NA 75100850Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07611996121834), received between Feb 19, 2020 and May 5, 2022 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SET-UP/INSPECTION OF A TOTAL HIP REPLACEMENT CASE, A TRIAL FEMORAL HEAD 32 S/+0 WAS NOTICED TO BE VERY WORN. UPON VISUAL INSPECTION, THE DEVICE WAS NOTICED TO BE FRACTURED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292014 ↗
• MalfunctionSep 17, 2021Crack; Crack

  IT WAS REPORTED THAT, THE LISTED DEVICES WERE CRACKED OR BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488030 ↗
• MalfunctionMay 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT 5 TRIAL HEADS HAD AN UNSPECIFIED FAILURE. UPON ARRIVAL, IT WAS NOTICED THAT ALL OF THEM HAD A BROKEN FIN. IT IS UNKNOWN WHEN THE FAILURE OCCURRED AND IF THERE WAS ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838402 ↗
• InjuryMay 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT 5 TRIAL HEADS HAD AN UNSPECIFIED FAILURE. UPON ARRIVAL, IT WAS NOTICED THAT ALL OF THEM HAD A BROKEN FIN. IT IS UNKNOWN WHEN THE FAILURE OCCURRED AND IF THERE WAS ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838378 ↗
• MalfunctionMay 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT 5 TRIAL HEADS HAD AN UNSPECIFIED FAILURE. UPON ARRIVAL, IT WAS NOTICED THAT ALL OF THEM HAD A BROKEN FIN. IT IS UNKNOWN WHEN THE FAILURE OCCURRED AND IF THERE WAS ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838283 ↗
• MalfunctionMay 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, WHILE THE TRIAL FEMORAL HEAD 32 S/+0 WAS INSIDE THE PATIENT, THE SURGEON NOTICED THAT DEVICE WAS WORN OUT, AND THE PLASTIC HAD FLEXED TO THE POINT THAT THE TRIAL NO LONGER GRIPPED ONTO THE TRIAL NECK SUFFICIENTLY. PROCEDURE CONTINUED WITH THE SAME DEVICE, WITHOUT A SURGICAL DELAY OR AN INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11780690 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED THAT AFTER A THR PROCEDURE, THE PLASTIC TABS OF THE TRIAL FEMORAL HEAD 32 S/+0 HAD BROKEN OFF. NO INJURIES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10523107 ↗
• InjuryAug 14, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE IT WAS FOUND THAT THE LOCKING TAB SNAPPED OFF. THE FRAGMENT WAS FOUND. SURGERY WAS NOT DELAYED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10407722 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS DEVICE BECOME DISLODGED. ADDITIONAL SKIN INCISION WAS NEEDED TO SOLVE THIS ISSUE. IT TOOK 1 HOUR TO TAKE THIS OFF FROM THE PATIENT'S BODY.

  Patient problems: Injury

  MAUDE report 9727779 ↗