V40 Head 6260-5-332Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327012934), received between Jan 23, 2019 and Jan 14, 2025 — classified as 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2025Material Erosion; Detachment of Device or Device Component; Material Erosion; Detachment of Device or Device Component

  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: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 21147482 ↗
• InjuryNov 4, 2024Degraded; Degraded

  AS REPORTED: "DR. CONTACTED ME LAST NIGHT STATING THAT THIS TMZF/LFIT FEMORAL HEAD HAD TRUNNIONOSIS AND THE NECK OF THE FEMORAL STEM HAD FRACTURED. HE IS REVISING THE STEM TODAY (B)(6) 2024." RIGHT HIP. SURGEON IS INQUIRING IF ANY IMPLANTS WERE RECALLED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20598127 ↗
• InjuryJun 17, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO THE TRUNNION BEING 'COMPLETELY ERODED AWAY.'

  Patient problems: Insufficient Information

  MAUDE report 19547919 ↗
• InjuryApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED REVISION SURGERY WAS REQUIRED AS IT WAS IDENTIFIED THROUGH X RAYS THAT THE HEAD HAD DISASSOCIATED FROM THE TRUNNION. IT WAS FURTHER REPORTED THAT THE ORIGINAL IMPLANT SURGERY WAS APPROXIMATELY 10 YEARS PRIOR.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16820453 ↗
• InjuryOct 3, 2022Degraded; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Degraded; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED BY THE CUSTOMER TO HEALTH CANADA THAT PATIENT PRESENTED WITH TOTAL HIP ARTHROPLASTY IMPLANT FAILURE (B)(6) 2022. PATIENT HAD ORIGINAL TOTAL HIP ARTHROPLASTY OF RIGHT HIP DONE (B)(6) 2008. 4 WEEKS PRIOR (B)(6) 2022, PATIENT NOTICED INCREASED DISCOMFORT IN RIGHT GROIN RADIATING DOWN TO KNEE, IN ADDITION TO A DEAD LEG FEELING, LIKE HE COULDN'T MOVE IT AROUND WELL AND HAD DECREASED RANGE OF MOTION (DIFFICULTY GETTING IN AND OUT OF CAR AND CHAIRS). PAIN WAS WELL MANAGED, NO ACUTE TRAUMA TO HIP, AND COULD WEIGHT BEAR. HOWEVER; AT THE BEGINNING OF FEBRUARY, PATIENT NOTICED A CREAKING NOISE AND WHEN IT DIDN'T GO AWAY HE CALLED SURGEON WHO INITIALLY COMPLETED SURGERY FOR APPOINTMENT. X-RAYS DONE AND A DISPLACED FRACTURE THROUGH NECK OF FEMORAL IMPLANT NOTICED. METAL ALKALOSIS WAS ALSO SEEN. REVISION SURGERY OF HIP COMPLETED ON (B)(6) 2022."

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Metal Related Pathology

  MAUDE report 15526548 ↗
• InjurySep 15, 2022Degraded; Fracture; Detachment of Device or Device Component; Unintended Movement; Degraded; Fracture; Detachment of Device or Device Component; Unintended Movement

  AS REPORTED BY REP: "CASE REPORT: PATIENT WHO UNDERWENT SURGERY APPROXIMATELY 12 YEARS AGO FOR A LEFT TOTAL HIP ARTHROPLASTY, PRESENTED WITH PAIN AND X-RAYS SHOWED A FEMORAL HEAD DISASSOCIATION FROM THE TRUNNION OF THE STEM. THE ORIGINAL STRYKER IMPLANTS IMPLANTED WERE: ACCOLADE TMZF SIZE 3X132 STEM, A 32+8 V40 COCR FEMORAL HEAD, A SIZE 50 TRIDENT PSL HA HEMISPHERICAL ACETABULAR SHELL, WITH NO SCREWS, AND SIZE 32 E 10° X3 POLYETHYLENE LINER. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM, A REVISION HIP WAS PERFORMED ON THE LEFT SIDE, THE HEAD WAS FRACTURED FROM THE TRUNNION ON THE STEM. REP CONFIRMED THE HEAD HAD WORN THE TRUNNION DOWN AND BECAME DISSOCIATED, THE STEM DID NOT FRACTURE, THE HEAD WAS FREE IN THE ACETABULUM CAUSING IMPINGEMENT AND METALLOSIS. THERE WAS ADVERSE LOCAL TISSUE REACTIONS FROM THE TRUNNIONOSIS HOWEVER THE ADDUCTORS WERE INTACT. ANOTHER COMPANY'S REVISION STEM WAS USED, THE TRIDENT CUP WAS RETAINED AND A NEW 36MM SIZE E 10 0° LINER WAS PUT INTO THE CUP."

  Patient problems: Foreign Body Reaction

  MAUDE report 15433456 ↗
• InjuryJun 27, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO THE TRUNNION BREAKING OFF FROM THE STEM (REPORTED AS 'RIGHT AT THE BEGINNING OF THE TRUNNION) INSIDE THE HEAD. THE HEAD, STEM, AND LINER WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 14826932 ↗
• InjuryNov 6, 2020Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO GROSS TRUNNION FAILURE. THE FEMORAL HEAD WAS REPORTED TO BE TOGGLING ON THE WORN DOWN TRUNNION, AND BLACK TISSUE WAS NOTED. THE PATIENT'S ENTIRE HIP CONSTRUCT WAS REVISED IN ORDER FOR THE SURGEON TO CLEAR ALL METAL DEBRIS FROM THE JOINT. THE REP CAN PROVIDE ADDITIONAL PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Metal Related Pathology

  MAUDE report 10799894 ↗
• InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HIP WAS REVISED DUE TO HEAD DISSOCIATION REPORTED AS GROSS TRUNNION FAILURE. BECAUSE OF THE AMOUNT OF METAL DEBRIS, LINER WEAR, AND IMPLANT STAINING, THE PATIENT'S ENTIRE HIP HAD TO BE REVISED. REP PROVIDED EXPLANT PICTURES AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 10585035 ↗
• InjuryOct 4, 2019Adverse 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), 2013 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 9156407 ↗
• InjuryMay 1, 2019Unstable; Unstable

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2011 (OUTSIDE CORS SCOPE). THEN PATIENT UNDERWENT RIGHT TOTAL HIP REVISION (B)(6) 2013. NOW THE PATIENT HAD A SECOND RIGHT TOTAL HIP REVISION FOR INSTABILITY WITH INSERTION OF MDM IN (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 8568815 ↗
• InjuryJan 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE ATTORNEY THAT PLAINTIFF UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2004 AND HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2017 DUE TO ALLEGED HEAD DISASSOCIATION (HD).

  Patient problems: Injury

  MAUDE report 8272533 ↗