Insignia 7000-6603Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327511512), received between Aug 15, 2023 and Feb 17, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Malposition of Device” (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
- Adverse Event Without Identified Device or Use Problem4
- Malposition of Device1
- Unstable1
- Use of Device Problem1
Patient problems
- Bone Fracture(s)3
- Ambulation or Postural Difficulties1
- Joint Laxity1
- Periprosthetic fracture1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT'S LEFT HIP REVISED DUE TO PERIPROSTHETIC FRACTURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Ambulation or Postural Difficulties; Periprosthetic fracture
MAUDE report 24362421 ↗InjuryNov 17, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device
InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A TRANSVERSE GREATER TROCHANTERIC FRACTURE OCCURRED FROM THE ROOT OF A PIN PLACED IN THE FEMUR POSTOPERATIVELY.
Patient problems: Bone Fracture(s)
MAUDE report 20667050 ↗InjuryAug 29, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INSTABILITY. THE FEMORAL SIDE OF THE CONSTRUCT WAS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 21/AUGUST/2024 WG: AS PER REVISION USAGE, THE ADM/ MDM POLY INSERT WAS ALSO REVISED. A RESTORATION MODULAR STEM CONSTRUCT, BIOLOX HEAD, AND ADM/ MDM POLY INSERT WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 20100327 ↗InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: REVISED A RIGHT HIP STEM/HEAD DUE TO PERIPROSTHETIC FRACTURE OF THE FEMUR.
Patient problems: Bone Fracture(s)
MAUDE report 17553687 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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