Insignia 7000-6607Recalls & 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
- 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 07613327511451), received between Feb 23, 2025 and Feb 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (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.
Reports received per month
Most reported problems
Device problems
- Degraded1
Patient problems
- Foreign Body Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2025Degraded; Degraded
AS REPORTED: "A PATIENT THAT HAD A LEFT PRIMARY DIRECT ANTERIOR HIP REPLACEMENT ON (B)(6) 2023. OVER 15 MONTHS LATER HE REPORTED PAIN AND LIMITED RANGE OF MOTION AND SUBSEQUENTLY FOLLOWED UP WITH DR., DR. SAW ON X-RAY THAT THERE WERE WHAT LOOKED TO BE FRACTURED PIECES OF THE PATIENTS BIOLOX DELTA V40 FEMORAL HEAD. THE PATIENT WAS THEN BROUGHT TO SURGERY FOR A HEAD AND LINER EXCHANGE REVISION SURGERY. INTRAOPERATIVELY: THE SURGEON NOTICED FRAGMENTED PIECES OF THE BIOLOX DELTA V40 AND THE FEMORAL HEAD WAS SPLIT IN HALF. THERE WERE SOME DARK STAINING OF THE SOFT TISSUES AND A SLIGHT METALLOSIS APPEARANCE. THE SURGEON REMOVED THE FEMORAL HEAD, REMAINING CERAMIC PIECES IN THE JOINT, AS WELL AS THE LINER, THE STEM AND CUP WERE WELL FIXED, NOT DAMAGED, AND THEN RETAINED. THE SURGEON THEN PUT A V40 TO C- TAPER ADAPTOR SLEEVE ON AND A NEW BIOLOX C-TAPER FEMORAL HEAD." REP REPORTED THAT THE (CONSULTANT) SURGEON WOULD LIKE INVESTIGATION RESULTS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Foreign Body Reaction
MAUDE report 21442650 ↗
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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