V40 Head 6260-5-328Recalls & reported problems
Howmedica Osteonics Corp. · V40 Femoral Head · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327012927), received between Aug 29, 2018 and Jun 6, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Degraded” (2 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
Device problems
- Degraded2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Injury2
- Joint Dislocation2
- Foreign Body Reaction1
- Inflammation1
- Metal Related Pathology1
- Reaction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 6, 2023Degraded; Degraded
AS REPORTED: "DR. PERFORMED A RIGHT HIP REV DUE TO ALTR." A HEAD, LINER, AND SHELL WERE REVISED.
Patient problems: Foreign Body Reaction
MAUDE report 17076214 ↗InjurySep 17, 2019Degraded; 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 AND LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2008 AND WAS REVISED ON (B)(6) 2011. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION AND EXPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.
Patient problems: Inflammation; Injury; Joint Dislocation; Metal Related Pathology; Reaction
MAUDE report 9075197 ↗InjuryAug 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO MULTIPLE DISLOCATIONS AND INSTABILITY. INTRA-OPERATIVELY, SEVERE POLY WEAR WAS NOTED. PATIENT WAS REVISED TO AN ADM/MDM LINER CONSTRUCT WITH A NEW SHELL AND HEAD.
Patient problems: Injury; Joint Dislocation
MAUDE report 7828606 ↗
Other Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish devices
- Arcos Modular Revision Hip System 11-301310Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall9 reports
- Arcos Modular Revision Hip System 11-301342Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish1 recall4 reports
- Tritanium 502-03-52DHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish39 reports
- V40 Head 6260-5-332Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish12 reports
- V40 Head 6260-9-032Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- EXETER 0580-1-443Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish11 reports
- Trident 509-02-56EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish10 reports
- Taperloc Complete Primary Femoral 51-104180Biomet Orthopedics, LLC · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.