V40 Head 6260-5-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327012842), received between Aug 22, 2017 and Jan 14, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Corroded” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 21, 2021Open, Classified

   There is a potential for the outer Tyvek lid to de-bond from the sealed package.

   Z-0644-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 21147434 ↗
• InjuryApr 25, 2023Corroded; Adverse Event Without Identified Device or Use Problem; Corroded; 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) 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. UPDATE: PER MEDICAL RECORDS RECEIVED. PATIENT ALSO EXHIBITED ALTR. CORROSION WAS OBSERVED, AT THE STEM-HEAD INTERFACE INTRAOPERATIVELY. THE TRUNNION WAS WIPED CLEAN AND THE STEM WAS LEFT IMPLANTED, AS IT WAS WELL-FIXED. THE SHELL WAS ALSO REVISED, AS THE SURGEON FELT THE PATIENT "WOULD BENEFIT FROM REVISION TO A LARGER CUP. WHICH IS MORE ANTEVERTED LESS VERTICAL".

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

  MAUDE report 16812423 ↗
• InjuryApr 3, 2023Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  THE NECK OF THE STEM WAS BROKEN. LIMITED ACTIVITIES.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Metal Related Pathology

  MAUDE report 16668847 ↗
• InjuryJun 28, 2022Corroded; Corroded

  IT HAS BEEN REPORTED "RE THA DUE TO ACETABULAR LOOSENING. ABNORMALITY WAS ALSO OBSERVED ON THE STEM SIDE. TRUNNIONOSIS AND METALLOSIS OCCURRED AT THE NECK-HEAD JUNCTION, AND THE AREA WAS DARKENED."

  Patient problems: Foreign Body Reaction

  MAUDE report 14846348 ↗
• InjuryFeb 11, 2021Adverse 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) 2007 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(S) AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HER BLOOD.

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 11318928 ↗
• InjuryJul 9, 2019Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  AS REPORTED: "PATIENT SITTING AND HEARD SNAP. X-RAY REVEALED BROKEN TRUNNION. LARGE METAL STAINING SEEN IN JOINT".

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 8771044 ↗
• InjuryApr 6, 2018Degraded; 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 HIS LEFT HIP ON OR ABOUT (B)(6) 2009 AND WAS REVISED ON (B)(6) 2017. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

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

  MAUDE report 7403658 ↗
• MalfunctionAug 22, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGE DIDN'T CONTAIN THE PRODUCT INSIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811005 ↗