V40 Head 6260-9-028Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327012996), received between Apr 9, 2018 and Dec 10, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 15, 2021Open, Classified

   XXX

   Z-0313-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Use of Device Problem; Use of Device Problem

  AS REPORTED VIA MEDWATCH MW5161760: A 63-YEAR-OLD FEMALE WAS BROUGHT TO THE OPERATING ROOM FOR A LEFT-SIDED HEMIARTHROPLASTY UNDER GA. THE SURGEON THEN IMPLANTED THE STRYKER OMNIFIT SIZE 6, 120MM EON C-TAPER STEM INTO THE FEMORAL CANAL. THE SURGEON THEN REQUESTED THE FEMORAL HEAD IMPLANT WITH A +2.5MM OFFSET TO PLACE ON THE IMPLANTED STEM. THE VENDOR REPRESENTATIVE WHO BROUGHT THE IMPLANTS TO THE OPERATING ROOM GAVE THE SURGEON A V40 FEMORAL HEAD WITH A 2.5MM OFFSET. THE SURGEON INSTALLED THE FEMORAL HEAD ON THE IMPLANTED STEM, TESTED THE SECURITY OF THE FIT AND PERFORMED A TRIAL REDUCTIONS AFTER APPLYING THE BIPOLAR HEAD. THE IMPLANTS WERE SECURE AND THERE WERE NO SIGNS OF INSTABILITY OF THE HIP DURING THE TRIAL REDUCTION. LATER THAT EVENING, INVESTIGATION REVEALED THAT THE STRYKER VENDOR (WHO WAS IN THE CASE) CONTACTED THE SURGEON AND NOTIFIED HIM THAT HE HAD GIVEN THE SURGEON A STRYKER V40 FEMORAL HEAD INSTEAD OF THE C-TAPER HEAD. THE V40 HEAD IS NOT COMPATIBLE WITH THE IMPLANTED STEM, AND ALTHOUGH COULD RESULT IN EARLIER FAILURE DUE TO FRETTING CORROSION AT THE MORSE TAPER CONNECTION. REVISION TO A C-TAPER HEAD TO MATCH THE STEM WAS DONE THE NEXT DAY. REVIEW OF THE TWO STRYKER

  Patient problems: Insufficient Information

  MAUDE report 20888714 ↗
• InjuryApr 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH DISLOCATED LEFT TOTAL HIP REPLACEMENT (EXETER, TRIDENT WITH MDM) FOLLOWING FALL DOWN STAIRS. HIP COULD NOT BE REDUCED AS A CLOSED REDUCTION. WHEN HIP JOINT WAS OPENED, SURROUNDING TISSUES WAS A GREY/BLACK COLOUR CONSISTENT WITH METALOSIS. 28MM LFIT HEAD HAD DISASSOCIATED FROM MDM HEAD. WHEN MDM LINER WAS REMOVED A SMALL METAL FRAGMENT WAS PRESENT IN THE JOINT. THIS FRAGMENT HAD NUMBERS ON IT CONSISTENT WITH THE LOT NUMBER FOR IMPLANTED TRIDENT HEMISPHERICAL SHELL. TRIDENT SHELL WAS EXPLANTED WHICH REVEALED WHERE METAL FRAGMENT HAD COME FROM. ACETABULUM WAS REAMED. A TRITANIUM MULTIHOLE CUP WAS IMPLANTED WITH MDM LINER AND HEAD.

  Patient problems: Bone Fracture(s); Inflammation; Injury; Joint Dislocation; Reaction

  MAUDE report 9963909 ↗
• InjuryFeb 11, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  AS REPORTED: "FEMORAL HEAD SWAP."

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Pain

  MAUDE report 9693262 ↗
• InjuryApr 26, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Injury; Metal Related Pathology; Pain

  MAUDE report 8557777 ↗
• InjuryApr 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REP REPORTED "PATIENT'S PELVIS FRACTURED ABOVE THE SADDLE DURING PHYSICAL THERAPY AND WILL HAVE TO BE REVISED. BEYOND THE REPORTED ILIAC WING FRACTURE, THERE IS THE PROBLEM OF DISLOCATION BETWEEN FEMORAL COMPONENT AND PELVIC PROSTHESIS WITH APPARENT DISASSOCIATION BETWEEN FEMORAL HEAD AND ANGLE ADAPTER TO THE FEMORAL STEM."

  Patient problems: Bone Fracture(s); Injury; Joint Dislocation

  MAUDE report 7409667 ↗