V40 Head 6260-4-122Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327012798), received between Jul 30, 2018 and May 20, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Degraded” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2025Degraded; Patient-Device Incompatibility; Degraded; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED:" AROUND AUTUMN 2024, THE PATIENT WAS FOUND TO HAVE A METAL (COBALT CHROME) ALLERGY, AND THERE WAS A POSSIBILITY THAT THE REVISION WOULD BE PERFORMED AGAIN. AFTER THAT, THE PATIENT REQUESTED THAT THE SURGERY BE PERFORMED. REVISION THA WAS PERFORMED ON THE PATIENT. ALTHOUGH THERE WAS NO LOOSENING OR MALPOSITIONING OF THE IMPLANTS OR ANY NOTICEABLE DAMAGE, DAMAGE TO THE SOFT TISSUE (PARTICULARLY THE GLUTEUS MEDIUS MUSCLE) WAS OBSERVED. WHEN THE IMPLANTS WERE REMOVED, WHITE TISSUE WAS FOUND TO BE STUCK TO THE INNER SURFACE OF THE CUP (BETWEEN THE TRIDENT II-MDM LINER). REQUEST FROM THE DOCTOR. ALTHOUGH IT IS THOUGHT THAT THIS PHENOMENON MAY BE DUE TO AN ALLERGIC REACTION OF THE PATIENT TO THE CO-CR ALLOY IMPLANT, THE DOCTOR BELIEVES THAT THERE MAY BE OTHER FACTORS INVOLVED, AS THE SOFT TISSUE DAMAGE WAS SEVERE AND THERE WAS A LOT OF TISSUE ADHESION BETWEEN THE CUP AND LINER. THE DOCTOR HAS REQUESTED THAT STRYKER INVESTIGATE THE EXTENT AND CAUSE OF DAMAGE AND WEAR OF THE DEVICES THAT WAS REMOVED ON (B)(6)."

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 22057199 ↗
• InjuryMar 1, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT HAS BEEN REPORTED BY THE CUSTOMER THAT AFTER PROCEDURE THE METAL HEAD WAS DISSOCIATED FROM THE STEM NECK. UPDATE 05/FEBRUARY/2021: AS ALSO REPORTED IN THE INTAKE FORM: "RETURNED TO (REVISE) THE PATIENT TO REMOVE THE IMPLANTED HEAD AND IMPLANTED BIPOLAR CUP AND PLACE A NEW ONE." UPDATE 08/FEBRUARY/2021, A HIP IMPLANTED ON (B)(6) 2021 FAILED AND WAS REVISED ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 11396701 ↗
• InjuryOct 17, 2019Unstable; Unstable

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2019. PROCEDURE: THE PATIENT HAD RIGHT TOTAL HIP REPLACEMENT OUTSIDE HOSPITAL (B)(6) 2011. AFTER THE HIP REPLACEMENT, PATIENT PRESENTED WITH INSTABILITY FAILURE, THEN UNDERWENT REVISION WITH REMAINING CUP, OTHER COMPONENTS EXCHANGED (B)(6) 2018. BECAUSE OF EXTENSIVE SOFT TISSUE DESTRUCTION THAT LED PATIENT PRESENTING SYMPTOM OF INSTABILITY, PATIENT UNDERWENT RIGHT TOTAL HIP REVISION LINER, HEAD, AND PROXIMAL RMS (BODY) COMPONENTS EXCHANGED ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9202366 ↗
• InjuryNov 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  "EVENT: PATIENT'S CONSTRAINED LINER DISLOCATED. CONSTRAINED LINER/ SHELL WERE REMOVED AND CONSTRAINED LINER IMPLANTED. ". UPDATE 25/OCTOBER/2018: REP REPORTED THE FOLLOWING: THE BIPOLAR DISLOCATED OUT OF THE LINER. CONSTRAINED LINER WAS SECURELY LOCKED IN SHELL. NEW HEAD WAS IMPLANTED INCREASING LENGTH FROM +0 TO +8. SURGEON CHOSE TO REVISE SHELL TO NEW TRITANIUM REVISION SHELL. OLD SHELL CAME OUT EASILY. NO POSSIBLE CAUSES FOR DISLOCATION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8090178 ↗
• InjuryJul 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE 22MM HEAD WAS WRONG TO IMPLANT WITH 26MM CUP AND LINER. THIS EVENT WAS FOUND AFTER OPERATION AND THE HEAD WAS CHANGED THE CORRECT SIZE.

  Patient problems: Injury

  MAUDE report 7731390 ↗