Orthinox 6364-2-232Recalls & reported problems
Howmedica Osteonics Corp. · V40 FEM HEAD · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540273390), received between Nov 2, 2021 and Nov 2, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Ambulation or Postural Difficulties1
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
PATIENT HAD A DISLOCATION OF THEIR LEFT HIP. THE ACETABULAR CUP WAS REMOVED AND A CEMENT IN CEMENT REVISION PERFORMED USING A 48MM CEMENTED CONSTRAINED CUP. THE HIP WAS REDUCED WITH A 22 + 3MM STAINLESS STEEL HEAD. UPDATE 14/JAN/2022: MEDICAL RECORDS INDICATE THAT THE EXETER STEM WAS NOT REVISED DURING THIS PROCEDURE. TIMELINE OF EVENTS PER MEDICAL RECORDS: FIRST REVISION ON (B)(6), 2014 DUE TO INFECTION, SECOND REVISION ON (B)(6), 2014 DUE TO RECURRENT DISLOCATIONS (THIS PI), AND THIRD REVISION ON (B)(6), 2021 DUE TO CONSTRAINED LINER IMPINGEMENT WHICH HAD LEAD TO EXCESSIVE PLASTIC WEAR AND THE LINER'S LOCKING RING BREAKING.
Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Joint Laxity
MAUDE report 12739868 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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