V40 Head 6260-9-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327013047), received between Feb 3, 2017 and May 1, 2025 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Degraded” (10 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Degraded; Degraded

  L) HIP REVISION TODAY DUE TO SUSPECTED TRUNIONOSIS. ORIGINAL SURGERY WAS L) HIP THA ON (B)(6) 2021. REVISION TODAY IN WHICH SURGEON FOUND BLACK DEBRIS AROUND FEMORAL NECK AND GROSS SEUDO TUMOUR AROUND SITE. REPLACED FEMORAL HEAD AND LINER.

  Patient problems: Foreign Body Reaction

  MAUDE report 21940913 ↗
• InjurySep 10, 2024Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED BY PATIENT'S COUNSEL AS A RESULT OF A LEGAL CLAIM THAT THE PATIENT UNDERWENT RIGHT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. ALLEGEDLY THE PATIENT DEVELOPED LATERAL HIP PAIN, HIGH COBALT-CHROME LEVELS AND MRI WAS CONSISTENT WITH A LARGE PSEUDOTUMOR. THE PATIENT WAS REVISED ON (B)(6) 2022 WITH A DIAGNOSIS OF ALTR/TAPER CORROSION.

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

  MAUDE report 20182226 ↗
• InjuryOct 4, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; 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 HER LEFT HIP ON OR ABOUT (B)(6) 2013, AND WAS REVISED ON (B)(6) 2022. IT IS FURTHER ALLEGED THAT THE PATIENT 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: Metal Related Pathology

  MAUDE report 17873714 ↗
• InjuryOct 5, 2022Corroded; Insufficient Device Problem Information; Corroded; 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) 2011 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 AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 15542057 ↗
• InjuryJul 5, 2022Degraded; Material Erosion; Degraded; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO METALLOSIS. A FEMORAL HEAD WAS REVISED TO A CERAMIC HEAD AND SLEEVE. REP CONFIRMED THAT PICTURES CAN BE PROVIDED. OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 14920886 ↗
• InjuryMay 13, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO TRUNNION WEAR. THE STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, AND LINER. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 14390045 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; 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 HER RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2020. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Metal Related Pathology

  MAUDE report 13878525 ↗
• InjuryFeb 11, 2022Degraded; Degraded

  LEFT HIP WASHOUT AND HEAD AND LINER CHANGE SECONDARY TO INFECTION. DOCTOR NOTED SIGNS OF MECHANICAL WEAR/EARLY METALOSIS OF THE HEAD AND DISCOLOURATION OF THE POLY LINER.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Unspecified Infection

  MAUDE report 13518842 ↗
• InjuryNov 17, 2021Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PSEUDOTUMOR AND ELEVATED COBALT AND CHROME LEVELS. INTRA-OPERATIVELY, BLACK DEBRIS WAS NOTED ON THE TRUNNION AFTER THE WELL-FIXED FEMORAL HEAD WAS REMOVED. THE HEAD AND LINER WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO REPORTED THAT PICTURES AND REVISION USAGE CAN BE PROVIDED, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 12833571 ↗
• InjurySep 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT REPORTED SHE HAD A LEFT THA ON (B)(6) 2014. THE PATIENT WAS REVISED (B)(6) 2016 DUE TO THE SCREWS GOING INTO THE TENDONS. THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE SURGERY. THE PATIENT WENT TO THE ER ON (B)(6) 2021 HAD A CT SCAN AND WAS TOLD SHE HAD LOBULAR FLUID SURROUNDING HER LEFT HIP AND WAS TOLD TO FOLLOW UP WITH HER PHYSICIAN. THE PATIENT'S PHYSICIAN SENT HER FOR BLOOD WORK WHICH WAS DONE ON (B)(6) 2021 WHICH SHOWED HIGH LEVELS OF CHROMIUM. PATIENT WAS REVISED ON (B)(6) 2021. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR REVISION 1. THE PATIENT'S PHYSICIAN SENT HER FOR BLOOD WORK WHICH WAS DONE ON (B)(6) 2021 WHICH SHOWED HIGH LEVELS OF CHROMIUM. PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 12432508 ↗
• InjuryJul 27, 2021Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO "SOME TRUNNION WEAR." THE FEMORAL HEAD AND LINER WERE REVISED TO A CERAMIC HEAD. SLEEVE, AND NEW LINER. REP PROVIDED INTRA-OP PICTURES. REP ALSO CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12235152 ↗
• InjuryJul 15, 2021Corroded; Detachment of Device or Device Component; Corroded; Detachment of Device or Device Component

  MEDICAL ASSISTANT FOR A SURGEON CALLED INQUIRING IF THE ACCOLADE TMZF STEM WAS PART OF A RECALL. IMPLANT INFORMATION FOR THE PATIENT'S HIP HAS BEEN REQUESTED. IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN IN THE LEFT HIP. UPDATE (B)(6) 2021 WG: AS REPORTED BY THE MEDICAL ASSISTANT: "...THE DEVICE BROKE AND THE PATIENT IS BEING TAKEN TO SURGERY TODAY."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12171685 ↗
• InjuryMay 12, 2021Corroded; Degraded; Adverse Event Without Identified Device or Use Problem; Corroded; Degraded; 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 RIGHT HIP ON OR ABOUT (B)(6) 2008 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(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

  Patient problems: Insufficient Information; Metal Related Pathology

  MAUDE report 11810931 ↗
• InjuryJul 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO ELEVATED COBALT LEVELS AND PAIN. A 32 +0 LFIT V40 HEAD AND 32E POLY LINER WERE REVISED TO ANOTHER POLY INSERT AND 36 +7.5 BIOLOX HEAD WITH SLEEVE. REP CAN PROVIDE ADDITIONAL PICTURES, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 10326282 ↗
• InjuryFeb 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT SUSTAINED INJURIES WHEN SHE WAS SURGICALLY IMPLANTED WITH A RECALLED PROSTHETIC HIP ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT SHE SUFFERED GREAT PHYSICAL AND EMOTIONAL DISTRESS FOR OVER ALMOST A YEAR UNTIL ITS REMOVAL ON (B)(6) 2019 AT WHICH POINT SHE DISCOVERED THAT THE PROSTHETIC HAD BEEN PREVIOUSLY RECALLED.

  Patient problems: Injury

  MAUDE report 9689110 ↗
• InjuryJul 1, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO METALLOSIS. INTRA- OPERATIVELY, A BLACK SUBSTRATE WAS NOTED ABOUT THE HEAD AND TRUNNION, AND A SIGNIFICANT AMOUNT OF BLACK TISSUE WAS OBSERVED IN THE PATIENT. A MERIDIAN STEM AND A 32 +0 LFIT V40 HEAD WERE REVISED TO A CERAMIC HEAD WITH SLEEVE AND A POLY LINER. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8748267 ↗
• MalfunctionJul 1, 2019Packaging Problem; Packaging Problem

  WHEN SCOUT NURSE OPENED OUTER BOX FOR IMPLANT 6260-9-132 LOT 69672005 IT WAS NOTICED THAT THE INNER PACK APPEARED TO BE MARKED. SHOWN TO OPERATING SURGEON AND DECIDED NOT TO USE THIS IMPLANT AND OPENED ANOTHER IMPLANT WITH SAME CAT NUMBER UPDATE 07 JUNE, 2019: REPORTER CONFIRMED A SURGICAL DELAY OF LESS THAN 2 MINUTES. UPDATE: "THE PATIENT WAS IN THE OPERATING ROOM AT THE TIME OF DISCOVERY AND WAS UNDER ANESTHESIA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748028 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A DISLOCATED LEFT HIP. XRAY INDICATED A DISSOCIATION OF THE STEM AND HEAD AS WELL AS A DAMAGED TRUNNION. A REVISION WAS PERFORMED AND ALL IMPLANTS WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 8603752 ↗
• 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 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, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

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

  MAUDE report 8558091 ↗
• InjuryFeb 11, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  ON OR ABOUT (B)(6) 2014, A REGISTERED NURSE TRIPPED AND FELL AT THE HOSPITAL LANDING ON HER RIGHT HIP. AS A RESULT OF THE ACCIDENT, SHE FRACTURED HER RIGHT HIP AND REQUIRED HER TO UNDERGO A TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2014 WHERE SHE HAD A STRYKER LFIT V40 HEAD IMPLANTED INTO HER BODY. ON (B)(6) 2017 PLAINTIFFS ORTHOPEDIC SURGEON ADVISED PATIENT OF THE ELEVATED LEVELS OF COBALT AND CHROMIUM IN HER BLOODWORK.

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

  MAUDE report 8327815 ↗
• InjuryJan 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011 AND AFTER IMPLANTATION DEVELOPED PAIN IN HER REPLACED HIP AND METAL ION TESTING DEMONSTRATED ELEVATED COBALT AND CHROMIUM LEVELS. THE PATIENT WAS REVISED ON (B)(6) 2017 AND DURING THE REVISION SURGERY "A VERY SIGNIFICANT AMOUNT OF CORROSION WAS EVIDENT AT THE BASE OF THE TRUNNION".

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 8224058 ↗
• InjurySep 26, 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 RIGHT HIP ON OR ABOUT (B)(6) 2007 AND WAS REVISED ON (B)(6) 2012. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE.

  Patient problems: Injury; Metal Related Pathology

  MAUDE report 7911402 ↗
• InjurySep 26, 2018Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  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) 2010 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT SHE SUFFERED INJURIES AS RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, AND EXCESSIVE LEVELS OF COBALT AND CHROMIUM IN HER BLOOD.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 7911151 ↗
• MalfunctionJun 25, 2018Material Discolored; Material Discolored

  HEAD WAS OPENED INTO STERILE FIELD, SURGEON RECOGNIZED THAT IT WAS DISCOLORED ( DARK BROWN IN THE TOP SECTION ONLY INSTEAD OF A SILVER COLOR), IT WAS NOT IMPLANTED THE V40 LFIT HEAD. THEATRE STAFF REPORTED THIS FAULTY ITEM TO MYSELF, STRYKER CNC, I TOOK PHOTOS, IT WAS DECONTAMINATED BY WASHING IN A TURBO WASHER AND THEN STERILIZING TO 135 DEGREES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635587 ↗
• MalfunctionDec 29, 2017Packaging Problem; Packaging Problem

  THE PACKAGE WITH IMPLANT OPENED; PAPER GOT SEPARATED WHEN OPENING AND BECAME UNSTERILE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7153949 ↗