V40 Head 6260-9-228Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327013061), received between Jul 10, 2018 and Feb 2, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Degraded” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: EXPLANTED ALL LEFT HIP IMPLANTS DUE TO CHRONIC INFECTION AND PLACED A TEMPORARY CEMENT SPACER. ORIGINAL PRIMARY WAS A COMPETITOR HIP IN 2014. THE STEM WAS REVISED TO A REST MOD ON (B)(6) 2025 AND THEN ON (B)(6) 2025 IT WAS CONVERTED TO A CONSTRAINED LINER.

  Patient problems: Unspecified Infection

  MAUDE report 24240513 ↗
• InjurySep 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF A STRYKER HEAD FROM A COMPETITOR LINER. PATIENT WAS REVISED TO A CONSTRAINED COMPETITOR LINER AND STRYKER FEMORAL HEAD (SAME CATALOG NUMBER AS WHAT WAS REMOVED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 17786495 ↗
• InjuryApr 11, 2022Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2006 AND WAS REVISED ON (B)(6) 2019. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14073768 ↗
• InjuryMay 12, 2021Corroded; Corroded

  HIP REVISION. ECCENTRIC POLY WEAR, MILD CORROSION SEEN IN FEMORAL HEAD. POLY WAS EXCHANGED, AND HEAD BALL (TITANIUM SLEEVE AND UNIVERSAL CERAMIC HEAD).

  Patient problems: Insufficient Information

  MAUDE report 11810906 ↗
• InjuryJan 3, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT : "WE HAVE RECEIVED A REPORT FROM OUR OPERATING ROOM REGARDING A HIP REPLACEMENT. REFERENCE: ABG II, BATCH NO.: 24725908. THIS WAS REMOVED FROM THE PATIENT FOR METALLOSIS. THE ADDITIONAL INFORMATION WE HAVE ON THIS PROSTHESIS IS AS FOLLOWS: HEAD REF: 28MM / 4 24725908, COLLAR REF: 5 MAX V40, ROD REF: IMPOSSIBLE TO SEE ".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9547802 ↗
• InjuryNov 27, 2019Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  SECOND STAGE REVISION OF TRITANIUM PRIMARY CLUSTER CUP WITH ADM & EXETER. ALL COMPONENTS REVISED DUE TO INSTABILITY & HEAD/ADM INSERT DISASSOCIATION. I FILED ANOTHER PI ON HIS SAME PATIENT ONE WEEK AGO WHEN IT WAS DISCOVERED THIS PATIENT HAD ALREADY BEEN REVISED ON THE (B)(6) 2019, AGAIN DUE TO DISASSOCIATION OF HEAD WITH ADM INSERT. UPDATE (B)(6) 2019 WG: SALES REP REPORTED THAT THE TRITANIUM PRIMARY SHELL AND EXETER STEM WERE ALSO REVISED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9383078 ↗
• InjurySep 5, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO WEAR OF THE METAL FEMORAL HEAD. SURGEON REPORTED THAT HE SUSPECTED THAT CERAMIC SHARDS REMAINED IN THE PATIENT FROM A 2016 REVISION (PI (B)(4)) WHICH CONTRIBUTED TO THE WEAR. BLACK TISSUE WAS NOTED INTRA-OPERATIVELY. THE PATIENT'S MDM/ ADM LINER CONSTRUCT AND 28 +4 LFIT FEMORAL HEAD WERE REVISED TO A 44G LINER AND 44MM BIOLOX HEAD WITH +4 SLEEVE. REP PROVIDED INTRA-OPERATIVE PICTURES, EXPLANT PICTURES, AND THE REVISION USAGE SHEET. THE REP MAY BE ABLE TO OBTAIN ADDITIONAL INFORMATION, BUT THE EXPLANTS ARE NOT AVAILABLE FOR RETURN.

  Patient problems: Injury

  MAUDE report 8966869 ↗
• InjuryMar 12, 2019Degraded; Material Deformation; Degraded; Material Deformation

  AS REPORTED: "ECCENTRIC WEAR, [AN MDM/ADM LINER CONSTRUCT AND FEMORAL HEAD WERE] REVISED TO 36E X3 LINER AND CERAMIC HEAD".

  Patient problems: Injury

  MAUDE report 8413351 ↗
• InjuryFeb 25, 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 COCR V40 FEMORAL HEAD ON HIS LEFT HIP ON OR ABOUT (B)(6) 2015 AND WAS REVISED ON (B)(6) 2016. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Reaction

  MAUDE report 8367149 ↗
• InjuryDec 28, 2018Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2013 AND HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICES AT ISSUE AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HIS BLOOD.

  Patient problems: Inflammation; Injury; Metal Related Pathology; Pain; Reaction

  MAUDE report 8204425 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. AS REPORTED BY REP: "SURGEON STATES PATIENT HAS HIP PAIN CONSISTENT WITH ADVERSE LOCAL TISSUE REACTION. PATIENT HAS ELEVATED COBALT LEVELS IN THE BLOOD". PATIENT WAS REVISED TO AN ADM INSERT AND BIOLOX DELTA HEAD WITH SLEEVE.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 7674726 ↗