EXETER 0580-3-321Recalls & reported problems
Howmedica Osteonics Corp. · EXETER STEM V40 · Class 2 · Implant
All models of EXETER (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 07613327123753), received between May 7, 2024 and Sep 19, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Loss of Osseointegration1
- Use of Device Problem1
Patient problems
- Insufficient Information2
- Ambulation or Postural Difficulties1
- Bone Fracture(s)1
- Inadequate Osseointegration1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2025Fracture; Fracture
NO NEW INFORMATION.
Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Insufficient Information
MAUDE report 23097691 ↗InjuryJul 21, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
SECOND STAGE REVISION. UPDATE: PATIENTS FIRST REVISION WAS OF NON-STRYKER DEVICES. THE SECOND REVISION WAS DUE TO IMPLANT LOOSENING.
Patient problems: Insufficient Information
MAUDE report 19788913 ↗InjuryMay 7, 2024Loss of Osseointegration; Loss of Osseointegration
SECOND REVISION SURGERY DUE TO LOOSENING OF STEM WAS PERFORMED ON (B)(6) 2024. STEM AND HEAD WERE EXPLANTED AND STEM, HEAD AND LINER WERE IMPLANTED. 1ST REVISION SURGERY WAS PERFORMED ON (B)(6) 2022. THIS PI IS FOR 2ND REVISION SURGERY.
Patient problems: Inadequate Osseointegration
MAUDE report 19264256 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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