Insignia 7000-5503Recalls & reported problems
Howmedica Osteonics Corp. · Hip Stem - Standard Offset · Class 2 · Implant
All models of Insignia (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327511413), received between Nov 7, 2022 and Mar 19, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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
- Failure to Osseointegrate1
Patient problems
- Bone Fracture(s)1
- Inadequate Osseointegration1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
THE REVISION WAS SECONDARY TO FEMORAL LOOSENING. THE FEMUR WAS REMOVED AND REVISED TO A COMPETITOR REVISION STEM AND THE INSERT WAS EXCHANGED FOR A NEW 36MM INSERT. NO FURTHER INFORMATION AVAILABLE FROM DOCTOR OR HOSPITAL.
Patient problems: Inadequate Osseointegration
MAUDE report 21642865 ↗InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RIGHT GREATER TROCHANTER FRACTURE INTRAOPERATIVE. INITIALLY BEING MANAGED CONSERVATIVELY. SCHEDULED ORIF POSSIBLE REVISION THA (B)(6) 2022. UPDATE: "BONE OBSERVED TO BE FRACTURED BY ONE OF THE INVESTIGATORS (B)(6) 2022 VIA X-RAY IMAGING. NO INSTRUMENTS OR IMPLANTS WERE IN CONTACT WITH THE BONE WHEN IT WAS OBSERVED TO BE FRACTURED. X-RAY IMAGING OCCURRED TO CONCLUDE FRACTURE AT EMERGENCY DEPARTMENT (B)(6) 2022. THE REVISION SURGERY HAS BEEN CANCELLED AND SUBJECT IS BEING TREATED CONSERVATIVELY AND BEING RECHECKED IN 3 WEEKS FOR FURTHER EVALUATION."
Patient problems: Bone Fracture(s)
MAUDE report 15749272 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, uncemented devices
- LFIT 6260-9-136Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented166 reports
- Trident 623-00-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented112 reports
- Accolade 6021-0435Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented88 reports
- EXETER 0580-1-044Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 recall22 reports
- Endo-Model SL Knee Prosthesis System 16-2840/02WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall17 reports
- Endo-Model SL Knee Prosthesis System 16-2840/05WALDEMAR LINK GmbH & Co. KG · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented1 recall12 reports
- Trident 623-10-36EHowmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented57 reports
- LFIT 6260-9-336Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, uncemented56 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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