V40 Head 6260-9-332Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327013122), received between Nov 17, 2015 and Dec 10, 2024 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2024Material Erosion; Material Erosion

  IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2013 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND ACCOLADE II HIP STEM. SHE WAS REVISED ON (B)(6) 2022 ALLEGEDLY DUE TO INCREASING PAIN, STIFFNESS, OSTEOLYSIS AROUND THE IMPLANT WITH DESTRUCTIVE BONY EROSION, AND ELEVATED COBALT AND CHROMIUM LEVELS.

  Patient problems: Metal Related Pathology; Osteolysis; Pain

  MAUDE report 20896242 ↗
• InjuryApr 15, 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) 2011 AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND AN ACCOLADE STEM. SHE UNDERWENT REVISION SURGERY ON (B)(6) 2023, DUE TO ALLEGED HEAD DISASSOCIATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19112452 ↗
• InjurySep 1, 2023Material Erosion; Material Erosion

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT ALLEGEDLY PLAINTIFF WAS IMPLANTED WITH AN ACCOLADE TMZF HIP STEM AND LFIT COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON MARCH 31, 2016, AND WAS REVISED ON (B)(6) 2021. IT IS FURTHER ALLEGED THAT X-RAY SHOWED THE FEMORAL NECK PORTION OF THE STEM DEFORMED AND ANGULATED.

  Patient problems: Insufficient Information

  MAUDE report 17668796 ↗
• InjuryNov 7, 2022Degraded; Degraded

  IT WAS REPORTED THROUGH A LEGAL CLAIM THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6), 2011 AND WAS REVISED ON (B)(6), 2021. THE REVISION OPERATIVE REPORT NOTED " DESTRUCTION OF THE TRUNNION, SEVERE METALLOSIS, SIGNIFICANT WEAR OF THE POLYETHYLENE AND METALLOSIS THROUGHOUT THE SYNOVIAL CAPSULE."

  Patient problems: Foreign Body Reaction

  MAUDE report 15742468 ↗
• InjuryAug 24, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INSTABILITY. A SHELL, 6 SCREWS, HEAD AND LINER WERE REVISED TO ANOTHER SHELL, LINER, SCREWS, AND HEAD.

  Patient problems: Joint Laxity

  MAUDE report 15284202 ↗
• InjuryJul 25, 2022Corroded; Corroded

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "CUP SPUN OUT OF ACETABULUM AND HEAD AND TRUNNION HAD CORROSION."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15099996 ↗
• InjuryApr 27, 2022Corroded; Corroded

  PATIENT HAD EFFUSION AND FLUID BUILDUP. PATIENT HAD A WASHOUT AND DEBRIDEMENT OF THEIR IMPLANTS. THE LINER AND HEAD WERE REVISED. RIGHT HIP. UPDATE PER MEDICAL REVIEW: "A PROCEDURE WAS UNDERTAKEN ON (B)(6) 2020. THERE WAS EVIDENCE OF TRUNNIONOSIS. NO STATEMENTS OF METAL DEBRIS WERE NOTED. IN THE PATIENT LETTER IT WAS STATED THAT THE SURGERY FOUND METALLOSIS AND TRUNNIONOSIS."

  Patient problems: Metal Related Pathology; Swelling/ Edema

  MAUDE report 14219048 ↗
• InjuryFeb 3, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  TRUNNION/HEAD DISSOCIATION. A LOT OF BLACK STUFF IN THE JOINT AND IMPLANTS. REVISED TO A RESTORATION MODULAR.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 13439473 ↗
• InjurySep 29, 2021Break; Material Erosion; Detachment of Device or Device Component; Break; Material Erosion; Detachment of Device or Device Component

  AS REPORTED: "AN ACCOLADE TMZF WAS BEING REVISED. REASON FOR THE REVISION IS THE FEMORAL HEAD BROKE OFF THE TRUNNION BECAUSE OF WEAR AND FRETTING AND POSSIBLE IMPINGEMENT. FAILURE OF BIG LFIT METAL HEAD AND TMZF TRUNNION." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, X-RAY AND EXPLANT PICTURES. RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12549621 ↗
• InjuryMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE HEAD BREAKING OFF THE TRUNNION. PATIENT IS ACTIVE AND INVOLVED WITH MANUAL LABOR. A FEMORAL HEAD AND RESTORATION MODULAR PROXIMAL BODY WERE REVISED. DUE TO INTRA-OPERATIVE DAMAGE TO THE STEM/ NECK JUNCTION, THE RESTORATION MODULAR DISTAL STEM WAS ALSO REVISED, ADDING 60 TO 90 MINUTES TO THE PROCEDURE (INTRA-OP EVENT REPORTED). REP CAN PROVIDE ADDITIONAL PICTURES AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 11/FEBRUARY/2021 (B)(4): THE REP IS UNAWARE IF THE SHELL OR LINER, WHICH ARE COMPETITOR DEVICES, WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11405372 ↗
• InjuryFeb 17, 2021Material Erosion

  REVISION SURGERY UPDATE (B)(6) 2021: THE SURGEON REPORTED THAT THE REVISION WAS DUE TO: TROCHANTERIC SYNDROME AND TRUNNIONOSIS. THE PATIENT FELT PAIN. HEAD AND LINER EXPLANTED. SLEEVE AND BIOLOX HEAD IMPLANTED ON DAMAGED TRUNNION. CHANGED THE LINER TO A 10 DEGREE LIP LINER, AND NOT PROCEEDING TO EXPLANT THE WELL FIXED FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 11340300 ↗
• InjuryAug 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  HE HAD A CEMENT MANTLE FRACTURE PROXIMAL RIGHT HIP. HAD A TRAUMATIC FALL (B)(6) 2019 - LOOSE, OTHER HIP REQUIRED DHS (NON-STRYKER PRODUCTS INVOLVED ON OPPOSITE HIP). PROXIMAL FEMORAL OSTEOLYSIS. NOTICED ON X-RAY UPON NOTICING PAIN AND AFTER THEIR TRAUMA. UPDATE: 27 JULY 2019: SURGEON WAS REVISING DUE TO SIGNS OF OSTEOLYSIS. NOTICED CEMENT MANTLE FRACTURE DURING PROCEDURE.

  Patient problems: Injury

  MAUDE report 10434945 ↗
• InjuryJul 13, 2020Corroded; 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 RIGHT HIP ON OR ABOUT (B)(6) 2010 AND WAS REVISED ON (B)(6) 2019. 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; Insufficient Information; Reaction

  MAUDE report 10263941 ↗
• InjuryApr 6, 2020Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO TRUNNION DAMAGE. AN ACCOLADE II STEM, 32 +8 LFIT V40 HEAD, AND 32D 10° INSERT WERE REVISED TO A 40F 0° INSERT, COMPETITOR STEM, COMPETITOR HEAD. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 11/MARCH/2020 WG: UPDATE RECEIVED FROM REP. PATIENT HAD AN CUP REVISION BETWEEN (B)(6) 2014 AND THE FEMORAL REVISION ON (B)(6) 2020. AN UNKNOWN INSERT WAS REVISED TO A 40F 0° INSERT. THE REP DOES NOT HAVE ACCESS TO ANY FURTHER INFORMATION AS TO THE DATE OR LOCATION OF THAT REVISION.

  Patient problems: Injury

  MAUDE report 9928387 ↗
• InjuryFeb 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "REMOVED STEM, LINER AND HEAD FROM PATIENT REPLACING WITH STRYKER RESTORATION STEM/ CONE BODY, CABLES AND MDM IMPLANTS. NO OTHER AND NO MORE INFORMATION AVAILABLE FROM HOSPITAL." REP CONFIRMED THAT THE FEMORAL HEAD DISASSOCIATED FROM THE STEM.

  Patient problems: Injury

  MAUDE report 9711666 ↗
• InjuryNov 19, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  AS REPORTED IN MEDWATCH # (B)(4) : "SURGEON DID SECOND REVISION AND REPLACED WITH STRYKER LFIT V40 FEMORAL HEAD. SINCE THEN MY COBALT SERUM LEVELS HAVE RISEN FROM 1.6 TO 2.2 IN 6 MONTHS. SURGEON CALLED ME FRIDAY AND SAID HE THINKS WE NEED TO REMOVE WHOLE IMPLANT, STEM AND ALL."

  Patient problems: Inflammation; Reaction

  MAUDE report 9340573 ↗
• MalfunctionNov 15, 2019Material Discolored; Material Discolored

  DURING TOTAL HIP REPLACEMENT, HOSPITAL STAFF (SCRUB NURSE) OPENED STERILE IMPLANT( LFIT HEAD) AND NOTICED IT WAS DISCOLOURED. IT WAS DARKER ON TOP AND THE SIDES REMAINED NORMAL SILVER COLOURING. THE SURGEON DID NOT WANT TO USE IT AND STAFF OPENED ANOTHER LFIT HEAD OF THE SAME SIZE WHICH WAS NOT DISCOLOURED. THIS WAS THEN USED TO COMPLETE THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328744 ↗
• InjuryAug 13, 2019Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED DUE TO THE TRUNNION BREAKING OFF THE STEM. A CITATION STEM, V40 36 HEAD, AND 0° G LINER WERE REVISED TO A COMPETITOR STEM AND HEAD WITH A STRYKER LINER.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8887649 ↗
• InjuryApr 26, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HER RIGHT HIP ON OR ABOUT (B)(6) 2005 AND WAS REVISED ON (B)(6) 2017. 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 IN HER BLOOD.

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

  MAUDE report 8555762 ↗
• InjuryJul 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A LEFT TOTAL HIP REPLACEMENT (B)(6) 2005. PATIENT HAS DONE WELL UNTIL RECENTLY. SHE SHOWED UP FOR FOLLOW UP WITH PAIN. SHE WAS WORKED UP AND HAD ELEVATED COCR LEVELS AND EVIDENCE OF A SOFT TISSUE MASS IN HER HIP. SHE WAS SCHEDULED FOR A REVISION. AT THE TIME OF REVISION SOME SOFT TISSUE REACTION WAS NOTED. THE HEAD WAS REMOVED WITH SEVERAL BLOWS WITH A MALLET AND TAMP. THERE WAS SOME BURNISHING OF THE HEAD AND NECK BUT IT APPEARED TO BE IN GOOD CONDITION. IT WAS CLEANED AND A NEW SLEEVE WAS IMPACTED AND TESTED. IT WAS SECURELY ATTACHED TO THE NECK. THE SURGEON SUBSEQUENTLY ASSEMBLED A CERAMIC HEAD AND MDM HEAD TOGETHER PLACED THE MDM LINER IN THE SHELL. HE THEN IMPACTED THE HEAD. IT WAS SECURE ON THE STEM. THE PATIENT WAS STABLE THROUGH A FULL RANGE OF MOTION. THE OPERATION WAS COMPLETED SUCCESSFULLY AND THE PATIENT WILL CONTINUE TO BE MONITORED. DUE TO HOSPITAL POLICY NO FURTHER INFORMATION WILL BE MADE AVAILABLE.

  Patient problems: Inflammation; Injury; Pain

  MAUDE report 7718318 ↗
• MalfunctionMar 2, 2017Failure to Align; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRIMARY RIGHT HIP DUE TO OSETOARTHRITIS. THE ISSUE WAS THE FEMORAL HEAD DID NOT SIT WELL ON THE TRUNNION. SURGEON REMOVED, CLEANED AND TRIED TWICE. ADDITIONAL DEVICE AVAILABLE. SURGERY COMPLETED SUCCESSFULLY, NO DELAY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6371862 ↗
• InjuryNov 17, 2015Device Dislodged or Dislocated

  PATIENT CALLED STRYKER STATING THAT SHE EXPERIENCED 2 DISLOCATIONS ON HER HIP.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 5230638 ↗