V40 Head 6260-9-232Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07613327013085), received between Jul 3, 2018 and Jun 23, 2025 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Degraded” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  CLAIMANT, THROUGH COUNSEL, ALLEGES THAT HE UNDERWENT A RIGHT THA ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE TMZF STEM. HE SUBSEQUENTLY WAS REVISED ON (B)(6) 2024, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22311014 ↗
• InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HIP WASHOUT, EXCHANGE HEAD 32MM +4 V40 LFIT. ROUTINE HEAD CHANGE DURING HIP WASHOUT FOR INFECTION. PROCEDURE AND REVISION OF COMPONENT NOT DUE TO IMPLANT FAILURE.

  Patient problems: Unspecified Infection

  MAUDE report 19687954 ↗
• InjuryJun 9, 2024Degraded; Degraded

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016, AND WAS IMPLANTED WITH AN LFIT V40 COCR FEMORAL HEAD AND ACCOLADE II HIP STEM REQUIRING REVISION SURGERY ON (B)(6) 2021, DUE TO ALLEGED METALLOSIS AND CORROSION.

  Patient problems: Metal Related Pathology

  MAUDE report 19495772 ↗
• InjuryApr 23, 2024Degraded; Degraded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2016 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE II HIP STEM. SUBSEQUENTLY SHE PRESENTED WITH INCREASING PAIN AND WORKUP SHOWED ELEVATED COBALT AND CHROMIUM LEVELS. SHE WAS REVISED ON (B)(6) 2022.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 19162861 ↗
• InjuryMar 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT ALLEGEDLY THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE TMZF STEM. HE UNDERWENT REQUIRED REVISION SURGERY ON (B)(6) 2022, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Insufficient Information

  MAUDE report 18928186 ↗
• InjuryNov 15, 2022Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated; Degraded; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO TRUNNION WEAR LEADING TO HEAD DISSOCIATION. THE HEAD AND STEM WERE REVISED. REP CAN PROVIDE PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15797295 ↗
• InjuryOct 21, 2022Material Erosion; Material Erosion

  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) 2012 AND WAS REVISED ON (B)(6), 2022. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction

  MAUDE report 15654883 ↗
• InjuryOct 12, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED DUE TO FAILURE OF THE FEMORAL NECK (REP CLARIFIED THE TRUNNION LOOKED GROUND DOWN AND THERE WAS A NOTCH IN THE NECK). THE STEM, HEAD, AND LINER WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15585386 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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) 2009 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14926578 ↗
• InjuryMay 27, 2022Material Erosion; Adverse Event Without Identified Device or Use Problem; Material Erosion; 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) 2021. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14521031 ↗
• InjuryFeb 9, 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) 2009 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Discomfort; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 13502313 ↗
• InjuryJan 31, 2022Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION HIP SURGERY DUE TO A DISSOCIATION BETWEEN THE HEAD AND FEMORAL STEM AND THE SUBSTANTIAL DAMAGE TO THE FEMORAL TRUNION. IT WAS FURTHER REPORTED THAT THE REVISION WAS PERFORMED AFTER THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH A DISLOCATION THAT APPEARED UNUSUAL ON XRAY >10 YEARS POST HIP REPLACEMENT.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 13392224 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM BROADSPIRE: IT WAS REPORTED THAT THE PATIENT HAS PAIN, METALLOSIS - ELEVATED LEVELS OF CHROMIUM & COBALT , CLICKING NOISE. ADDITIONAL INFORMATION RECEIVED FROM LEGAL: PLAINTIFF ALLEGES THE LEFT REJUVENATE HIP IMPLANTED ON OR ABOUT (B)(6) 2010 FAILED CAUSING PAIN AND ELEVATED METAL ION LEVELS. PLAINTIFF HAS NOT YET SCHEDULED REVISION SURGERY. AS REPORTED BY REP: "REVISION OF LEFT TOTAL HIP. PATIENT HAD REJUVENATE STEM REMOVED...PATIENT COBALT LEVEL WAS 18." SPOKE TO REP. A REJUVENATE MODULAR STEM AND NECK, AND COCR HEAD WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction

  MAUDE report 13313428 ↗
• InjuryJan 14, 2022Unstable; Unstable

  THIS PI IS FOR THE RECURRENT DISLOCATIONS ENDING IN (B)(6) 2021. IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR (B)(4) FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2012 AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD. MEDICAL RECORDS INDICATED THAT THE PATIENT HAD RECURRENT DISLOCATIONS, WITH THE FINAL DISLOCATION OCCURRING IN (B)(6) 2021.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 13257063 ↗
• InjurySep 30, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. THE PATIENT HAD FALLEN AND THE HEAD DISASSOCIATED FROM THE STEM. INTRAOPERATIVELY, THE SURGEON NOTICED THAT THERE WAS A LOT OF WEAR AROUND THE TRUNNION. REP NOTED THAT "THE TIP OF THE TRUNNION WAS GONE." REP HAS THE IMPLANTS FOR RETURN.

  Patient problems: Ambulation or Postural Difficulties; Fall

  MAUDE report 12554362 ↗
• MalfunctionSep 2, 2020Contamination; Contamination

  CONTAMINATED FEMORAL HEAD, MOISTURE APPEARS TO HAVE PENETRATED BOTH BOXES INSIDE PACKAGING BUT OUTER PACKAGE AND PLASTIC WERE INTACT AND NO SIGN OF MOISTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10482174 ↗
• InjuryJun 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT EXPERIENCED PAIN IN BACK/ HIP AROUND (B)(6) 2018. IN SUBSEQUENT VISITS A FLUID/ TISSUE MASS WAS SEEN ON IMAGING. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. ORIGINAL SURGERY WAS IN 2009. DARK FLUID AND TISSUE WAS SEEN IN JOINT. STEM WAS REMOVED AND REPLACED WITH A LONG CEMENTED STEM, CUP WAS RETAINED".

  Patient problems: Injury; Pain

  MAUDE report 8697204 ↗
• InjuryFeb 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LEGAL CLAIM, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT ACETABULAR HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT IS EXPERIENCING "LOOSENING AND DISCOMFORT" FROM THE SYSTEM. UPDATE FROM MEDICAL REVIEW: A REVISION OF THE RIGHT TOTAL HIP ARTHROPLASTY ACETABULAR COMPONENT WAS PERFORMED FOR A DIAGNOSIS OF ACETABULAR LOOSENING AND METALLOSIS. THE LINER SHOWED "ANTERIOR IMPINGEMENT". THE STEM WAS RETAINED AS THE TAPER WAS NOTED TO BE "ACCEPTABLE".

  Patient problems: Discomfort; Inadequate Osseointegration; Inflammation; Injury; Reaction

  MAUDE report 8373695 ↗
• InjuryFeb 25, 2019Corroded; Corroded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO ELEVATED CHROMIUM LEVELS, AND SUSPECTED CORROSION OF THE HEAD/ TRUNNION INTERFACE. INTRA-OPERATIVELY, CORROSION WAS CONFIRMED. A STEM, HEAD AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, CERAMIC HEAD, AND MDM/ADM LINER CONSTRUCT. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8367293 ↗
• InjuryFeb 22, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  AS REPORTED: "PATIENT WAS BROUGHT IN FOR A HIP REVISION. PATIENT WAS HAVING PAIN AND HIGH COBALT LEVELS INDICATED METALLOSIS PER [SURGEON]. EXPLANTED HEAD AND LINER BUT RETAINED STEM. METAL DEBRIS AND SOFT TISSUE DAMAGE NOTED, DAMAGE TO TRUNNION OF STEM BUT DIDN'T WARRANT PULLING IMPLANT. [SURGEON] HAD TO DEBRIDE SOFT TISSUE AND REPAIR TO THE BEST OF HIS ABILITY. REPLACED HEAD AND LINER". PATIENT WAS REVISED TO A 36 +5 BIOLOX HEAD AND SLEEVE AND 36E LINER.

  Patient problems: Foreign Body Reaction; Injury; Pain; Reaction

  MAUDE report 8362372 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 HIS LEFT HIP ON (B)(6) 2011 AND WAS REVISED ON (B)(6) 2015. IT IS FURTHER ALLEGED THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION 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 7968762 ↗
• InjurySep 13, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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) 2009 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, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

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

  MAUDE report 7873923 ↗
• InjuryJul 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISASSOCIATION OF TRUNION/FEMORAL HEAD. PATIENT IDENTIFIED AFTER 2007 PRIMARY HIP SURGERY. PATIENT REQUIRED REVISION HIP SURGERY.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 7659722 ↗