V40 Head 6260-5-232Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327012903), received between Jun 13, 2018 and Jan 14, 2025 — classified as 11 injuries.

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

• InjuryJan 14, 2025Material Erosion; Material Erosion

  IT WAS REPORTED THAT ¿TRUNNIONOSIS OF HIP IMPLANT - RESULTING IN BROKEN IMPLANT NEEDING TO BE REVISED SURGICALLY¿. THIS EVENT WAS REPORTED TO STRYKER CANADA BY HEALTH CANADA VIA MANDATORY HOSPITAL REPORTING: HEALTH CANADA REFERENCE #: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 21147435 ↗
• InjuryAug 24, 2023Degraded; Material Erosion; Detachment of Device or Device Component; Degraded; Material Erosion; Detachment of Device or Device Component

  THE NECK OF THE ACCOLADE TMZF WAS DAMAGED DUE TO WEAR, WHICH CAUSED THE METAL HEAD TO COME OFF. METALOSIS WAS ALSO CONFIRMED DURING REVISION SURGERY.

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

  MAUDE report 17609800 ↗
• InjuryJan 21, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  RIGHT SIDE HIP REVISION, ALL COMPONENTS EXPLANTED WERE STRYKER COMPONENTS. THE PATIENT WAS RE-IMPLANTED WITH NEW REVISION STRYKER COMPONENTS. THE PATIENT RECENTLY WAS REPORTING PAIN IN HER RIGHT HIP, X-RAYS SHOWED A DISASSOCIATION AND INTRAPROSTHETIC DISLOCATION OF THE FEMORAL HEAD FROM THE TRUNNION OF THE STEM. THE PATIENT¿S COBALT CHROME LEVELS WERE ELEVATED AND THE STEM/FEMORAL HEAD JUNCTION WAS FAILED, SO THE SURGEON NEEDED TO REVISE THE FEMORAL COMPONENT. THERE WERE ADVERSE LOCAL TISSUE REACTIONS SURROUNDING THE COMPONENT, THE FEMORAL HEAD HAD CORROSION AND SEVERE WEAR WAS NOTED ON THE TRUNNION AS THE FEMORAL HEAD WAS FRACTURED OFF.

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

  MAUDE report 13314414 ↗
• InjuryDec 10, 2021Corroded; Material Erosion; Loss of Osseointegration; Corroded; Material Erosion; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND SUPERIOR LUCENCY AROUND THE ACETABULAR SCREWS. INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: SOME TISSUE STAINING, CORROSION INSIDE OF THE FEMORAL HEAD (NO CORROSION OR WEAR WAS NOTED ON THE TRUNNION), AND ONCE THE SCREWS WERE REMOVED, THE SHELL CAME OUT EASILY. THE HEAD, LINER, SHELL, AND SCREWS WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP CAN PROVIDE PICTURES AND OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12980523 ↗
• InjuryAug 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH PERIPROSTHETIC HIP FRACTURE. REVISION WAS DONE. *UPDATE ON 10-JUL-2020: "(B)(6) 2017 OP NOTE - REVISION LEFT TOTAL HIP  PRE/POST-OP DIAGNOSIS "FAILURE LEFT TOTAL HIP REPLACEMENT" GEN ANESTHESIA, "EXTENDED TROCHANTERIC OSTEOTOMY. SIGNIFICANT TITANIUM DEBRIS. FEMORAL STEM WELL FIXED. TRUNNION ERODED. BEAKLIKE IN SHAPE. HEAD DISASSOCIATED. ACET. SHELL WELL FIXED. " PER CLINICIAN REVIEW COMMENT: "THE EVENT DESCRIPTION STATES "PERIPROSTHETIC FRACTURE" BUT THE REVISION OP REPORT DESCRIBES A PROSTHETIC DISASSOCIATION AND EROSION. BASED UPON THE INFORMATION AVAILABLE FOR REVIEW, NO CREATION OF A MEDICAL REPORT IS POSSIBLE FOR THIS CASE."

  Patient problems: Injury

  MAUDE report 10375815 ↗
• InjuryApr 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH A MEDWATCH 5093292: "PATIENT ID:[...]; ON [...] 2006, HE UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY WITH STRYKER (HOWMEDICA) COMPONENTS, UNCEMENTED PSL 54 OD SOCKET, 32MM CROSSFIRE POLYETHYLENE INSERT. ACCOLADE HFX STEM SIZE 3 (REF #6077-03358), AND A 32MM +4 LFIT ANATOMIC V40 HEAD (REF #6077-0335) AND A 32MM +4 LFIT ANATOMIC V40 HEAD (REF #6260-5-232). IN [...] OF 2016, HE HAD A SUDDEN EPISODE OF WEAKNESS IN THE RIGHT LEG, WHICH CONCERNED HIM AND PROMPTED EVALUATION OF HIS RIGHT HIP REPLACEMENT. IN THE YEAR PRECEDING THAT EPISODE, HE HAD BEEN EXPERIENCING A SIGNIFICANT TREMOR OF HIS HANDS, FATIGUE AND REDUCED STAMINA. METAL SUPPRESSION MRI OF RIGHT HIP ON [...] 2016 SHOWED A SMALL PSEUDOTUMOR JUST SUPERIOR TO THE FEMORAL NECK WITH INVOLVEMENT OF THE GLUTEUS MEDIUS TENDON. FDG PET BRAIN SCAN AND NEURO Q ANALYSIS SHOWED ABNORMAL HYPOMETABOLISM IN FOCAL AND GENERALIZED DUSTER REGIONS IN A PATTERN COMPATIBLE WITH CHRONIC TOXIC ENCEPHALOPATHY. ON [...] 2016, SERUM/ PLASMA COBALT LEVEL WAS 5.8 MCG/L AND CHROMIUM WAS 1.7MCG/L. ON [...] 2016, RIGHT HIP WAS REVISED TO A ZIMMER WAGNER STEM 190 BY 14MM, TRIDENT X3 32ID LATERALLY OFFSET LINER, A 32MM DELTA CERAMIC +0 HEA

  Patient problems: Injury; Reaction

  MAUDE report 9944146 ↗
• InjuryMar 2, 2020Material Erosion; Material Erosion

  AT (B)(6) 2012, THA WAS DONE WITH ACCOLADE TMZF, TRIDENT CUP, X3 LINNER AND METAL HEAD V40 TEPER. AT (B)(6) 2020, THE PATIENT FELT UNCOMFORTABLE AND WENT TO THE HOSPITAL. EXAMINATION AT THE HOSPITAL CONFIRMED TRUNNIONOSIS AND THE REVISION SURGERY OF STEM, LINNER, HEAD IS SCHEDULED FOR AROUND (B)(6) 2020.

  Patient problems: Injury

  MAUDE report 9775869 ↗
• InjuryFeb 24, 2020Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  2019/DEC, IT WAS COMFIRMED A ARMD (ADVERSE REACTIONS TO METAL DEBRIS). ON (B)(6) 2020 REVISION SURGERY DID. IT WAS NO TRANIONOSIS.

  Patient problems: Injury

  MAUDE report 9746617 ↗
• InjurySep 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PAIN & SHORTENING LEG. X-RAY REVEALED HEAD [DISASSOCIATED] FROM STEM. ALL AVAILABLE INFORMATION SUBMITTED." PATIENT WAS REVISED TO "RESTORATION W/ MDM." REP PROVIDED EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9109041 ↗
• InjuryAug 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN IN RIGHT HIP AT THE EMERGENCY DEPARTMENT. THE PATIENT REPORTED THE PAIN STARTED APPROXIMATELY ONE YEAR AGO. IT WAS FURTHER REPORTED THAT A SUBSEQUENT X-RAY SHOWED HEAD DISSOCIATED FROM STEM. PATIENT REQUIRED REVISION HIP SURGERY TO REMOVE HIP STEM.

  Patient problems: Injury; Pain

  MAUDE report 8873362 ↗
• InjuryJun 13, 2018Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  THE PATIENT UNDERWENT THA SURGERY WITH CENTPILLAR ON (B)(6) 2009. THE PATIENT CLAIMED ABNORMAL SOUND FROM THE LEFT HIP AND A DISLOCATION OF THE METAL HEAD WAS CONFIRMED. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, AND AN INSERT, THE METAL HEAD AND THE STEM WERE REPLACED. WEAR OF THE STEM NECK WAS NOTICED. ALSO, INSIDE OF THE PATIENT'S HIP JOINT WAS BLACK BY METAL ABRASION POWDER.

  Patient problems: Injury; Reaction

  MAUDE report 7597103 ↗