V40 Head 6260-9-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327013009), received between Oct 31, 2017 and Jan 6, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT THA ON (B)(6) 2012 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF HIP STEM. HER RIGHT HIP WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO ELEVATED METAL IONS AND MRI FINDINGS CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION.

  Patient problems: Foreign Body Reaction

  MAUDE report 21081848 ↗
• InjuryApr 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT REQUIRED A TOTAL HIP REVISION SURGERY DUE TO FAILURE OF THE HEAD-TRUNNION JUNCTION. THE PATIENT HAD PRESENTED TO THE ER WITH DISLOCATION OF THE FEMORAL HEAD WHICH WAS CONFIRMED UPON ADMITTANCE. IT WAS FURTHER REPORTED THAT THE REVISION INVOLVED REMOVAL OF THE TRIDENT ACETABULAR LINER, V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. THE ORIGINAL SHELL WAS LEFT IN PLACE.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 16713028 ↗
• InjuryJun 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REP WAS NOTIFIED BY SURGEON THAT A PATIENT HAS HIP PAIN AND WANTED TO KNOW IF THE PATIENT'S FEMORAL HEAD WAS SUBJECT TO RECALL. REP WAS NOTIFIED HEAD IS NOT SUBJECT OF RECALL, SURGEON WAS NOTIFIED BY THE REP. IT IS UNKNOWN AT THE TIME OF REPORT IF THERE IS ANY TREATMENT PLAN FOR THIS PATIENT. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON AT THE TIME OF REPORT, BUT WILL UPDATE IF ANY NEW INFORMATION BECOMES AVAILABLE.

  Patient problems: Pain

  MAUDE report 10137709 ↗
• InjuryApr 2, 2020Corroded; Corroded

  PATIENTS HIP WAS REVISED FOR SUSPECTED INFECTION AND ACETABULAR LOOSENING. INFECTION LABS WERE FOUND TO BE NEGATIVE, BUT THERE WAS MARKED CORROSION ON THE FEMORAL STEM AND HEAD. PATIENTS ACETABULUM WAS REPLACED WITH A TRIDENT II MULTIHOLE SHELL AND 40MM LINER. FEMORAL HEAD WAS REPLACED WITH +0 40MM BIOLOX UNIVERSAL HEAD AND SLEEVE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9918105 ↗
• InjuryOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO RECURRENT DISLOCATIONS OF A STRYKER FEMORAL HEAD AND A COMPETITOR LINER. THE LFIT V40 FEMORAL HEAD AND COMPETITOR DEVICES WERE REVISED TO STRYKER DEVICES. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9165812 ↗
• InjuryOct 4, 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 LEFT HIP ON OR ABOUT (B)(6) 2006 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: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 9155850 ↗
• InjuryFeb 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING AN INFECTION CASE IT WAS NOTICED METALLOSIS AROUND THE HEAD AND ACCORDING TO SURGEON ALVAL CASE. THE HEAD WAS REVISED. THE PATIENT HAD AN ABG2 WITH LFIT V40 HEAD. THE PATIENT GOT A UNIVERSAL BIOLOX DELTA HEAD WITH V40 SLEEVE.

  Patient problems: Inflammation; Injury; Reaction; Unspecified Infection

  MAUDE report 8367087 ↗
• InjuryAug 28, 2018Corroded; Corroded

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED DUE TO SUSPECTED CORROSION (ION LEVELS NOT REPORTED TO REP). REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 7823434 ↗
• InjuryDec 6, 2017Material Discolored; Material Discolored

  PATIENT HAD A TOTAL HIP IN (B)(6) 2011 AND RECENTLY COMPLAINED OF PAIN. A BONE SCAN SHOWED THAT THE CUP WAS LOOSE AND IT WAS REVISED. THERE WAS EVIDENCE OF BLACK STAINING IN THE HEAD AND AROUND THE NECK OF THE IMPLANT.

  Patient problems: Injury; Pain

  MAUDE report 7089489 ↗
• MalfunctionNov 15, 2017Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  AN IMPLANT WAS OPENED AND HAIR WAS FOUND. THE NURSE TOOK IT AWAY SO IT NEVER CAME IN CONTACT WITH PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7032586 ↗
• MalfunctionOct 31, 2017Fitting Problem; Fitting Problem

  SURGEON REPORTED THAT WHEN HE PLACED DEFINITIVE HEAD ON TO EXETER STEM, THE HEAD FIT LOOSELY. AFTER IMPACTING WITH HEAD IMPACTOR AND MALLET, THE HEAD WAS ABLE TO BE REMOVED BY HAND. ANOTHER HEAD WAS OPENED AND USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6991535 ↗