V40 Head 6260-5-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327012835), received between Jul 10, 2018 and Jan 28, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PATIENT UNDERGOING ARTHROSCOPIC REVIEW DUE TO LOOSENING OF THE METALLIC HEAD OF THE NAIL CONE.

  Patient problems: Pain

  MAUDE report 16261350 ↗
• InjurySep 21, 2020Break; Break

  THE DOCTOR REVISED THE PATIENT'S TOTAL HIP PROSTHESIS DUE TO THE BREAKAGE OF THE EXETER NAIL IMPLANTED IN THE PATIENT.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 10559259 ↗
• MalfunctionApr 17, 2020Mechanical Problem; Mechanical Problem

  PATIENT CALLED STATING SHE HAD A LEFT HIP REPLACEMENT DONE (B)(6) 2014, SHE WOULD LIKE TO KNOW IF HER IMPLANTS WERE INVOLVED IN A RECALL. PATIENT IS ASYMPTOMATIC AT THE TIME OF THIS CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9972630 ↗
• InjuryJul 10, 2018Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  REVISION OF LUXATED HIP REVEALED MASSIVE LOSS OF SOFT TISSUE AROUND GREATER TROCHANTER AND ACCOMPANYING PARTICLE DEBRIS AROUND THE SPIGOT, INSIDE THE HEAD TRUNNION AND IN THE WOUND AS A BLACK PATTERN. THE PRODUCTS REVISED WERE ACCOLADE TMZF WITH TRIDENT CUP. THE STEM, HEAD AND LINER WERE RETRIEVED AND AVAILABLE FOR FURTHER INSPECTION. AS TO MARKS ON THE STEM, THE SURGEON USED ONLY OSTEOTOMY AROUND THE PROXIMAL PART OF THE FIXATION ZONE AND NOT ON THE TRUNNION. MARK ON THE HEAD ONLY ON THE OUTSIDE TO TAP OUT THE HEAD. THE STEM WAS WITHDRAWN WITH THE THREADED ACCOLADE2 INSERTER. NO OTHER MARKS WERE CAUSED BY USING OSTEOTOMY OR OTHER INSTRUMENT.

  Patient problems: Injury; Joint Dislocation; Tissue Damage

  MAUDE report 7674936 ↗