Insignia 7000-6604Recalls & reported problems
Howmedica Osteonics Corp. · Hip Stem - High Offset · Class 2 · Implant
All models of Insignia (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327511536), received between Dec 2, 2024 and Nov 3, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Human-Device Interface Problem2
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Periprosthetic fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MalfunctionDec 3, 2024Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem
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
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20830509 ↗MalfunctionDec 2, 2024Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem
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
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20818806 ↗
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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