InsigniaRecalls & reported problems across all models
Howmedica Osteonics Corp. · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 46
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 0
We found 15 models of Insignia by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2022 and Sep 25, 2026 — classified as 44 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (5 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Insignia problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Loss of Osseointegration5
- Use of Device Problem4
- Degraded3
- Malposition of Device3
- Migration3
- Osseointegration Problem3
- Human-Device Interface Problem2
Patient problems
- Bone Fracture(s)19
- Inadequate Osseointegration10
- Pain9
- Insufficient Information5
- Fall4
- Periprosthetic fracture4
- Ambulation or Postural Difficulties2
- No Clinical Signs, Symptoms or Conditions2
Insignia models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Insignia 7000-6605Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10 reports
- Insignia 7000-6606PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED9 reports
- Insignia 7000-6603Prosthesis, hip, hemi-, femoral, metal5 reports
- Insignia 7000-6602Prosthesis, hip, semi-constrained, metal/polymer, uncemented5 reports
- Insignia 7000-5505Prosthesis, hip, hemi-, femoral, metal4 reports
- Insignia 7000-6604PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 reports
- Insignia 7000-5503Prosthesis, hip, semi-constrained, metal/polymer, uncemented2 reports
- Insignia 7000-5504Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Insignia 7000-5507Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Insignia 7000-5506Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Insignia 7000-6607PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Insignia 7000-5508Prosthesis, hip, hemi-, femoral, metal1 report
- Insignia 7000-6601Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Insignia 7000-5500Prosthesis, hip, semi-constrained, metal/polymer, uncemented1 report
- Insignia 7000-6608PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Recent Insignia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
The following information was provided: Patient revised due to periprosthetic fracture. No other information available due to hospital policy.
Patient problems: Periprosthetic fracture
MAUDE report 50896024 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
The following was reported: "Revised a right hip due to periprosthetic femoral fracture. He revised the head and stem to a competitor, and kept the original cup and liner. He was unsure when the fracture had occurred. Rep confirmed that no further information will be released by the hospital or surgeon".
Patient problems: Bone Fracture(s)
MAUDE report 50855352 ↗InjuryMay 28, 2026Noise, Audible
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO SQUEAKING. THE HIP CONSTRUCT HAD A POLY LINER WITH A CERAMIC HEAD, BUT THE SURGEON SUSPECTS THAT THERE IS A POSSIBLE UNSPECIFIED ISSUE INSIDE THE HEAD. THE HEAD AND LINER WERE REVISED TO A NEW POLY LINER WITH METAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Discomfort
MAUDE report 25314898 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISION. REASON UNCONFIRMED. LEFT HIP. AN INSIGNIA STEM, METAL FEMORAL HEAD, AND MDM POLY INSERT WERE REVISED TO AN EXETER STEM, METAL FEMORAL HEAD, MDM POLY INSERT, AND COMPETITOR CEMENT.
Patient problems: Insufficient Information
MAUDE report 24676499 ↗InjuryFeb 25, 2026Loss of Osseointegration; Migration
THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT HIP INSIGNIA STEM DUE TO SUBSIDENCE WHICH CAUSED PAIN FOR THE PATIENT. HE REVISED THE LINER FROM A 44 TO A 40 AND REMOVED THE ACETABULAR SCREW. HE REVISED THE STEM TO A COMPETITOR STEM. UPDATE REGARDING REVISED LINER AND SCREW: NO ALLEGATIONS AGAINST THE IMPLANT. HE REMOVED THE SCREW BECAUSE IT WAS NO LONGER NEEDED. HE CHANGED FROM A 44 TO A 40 LINER BECAUSE COMPETITOR DIDN'T HAVE A 44 HEAD OPTION.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 24443598 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT'S HIP REVISED DUE TO PERIPROSTHETIC FEMORAL FRACTURE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Periprosthetic fracture
MAUDE report 24433782 ↗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 ↗InjuryDec 22, 2025Malposition of Device; Migration; Malposition of Device; Migration
PATIENT'S RIGHT HIP REVISED DUE TO STEM SUBSIDENCE. THERE WERE NO FRACTURES. PATIENT WAS CONVERTED FROM A HEMI TO A TOTAL HIP WAS DUE TO PAIN. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.
Patient problems: Pain
MAUDE report 23863419 ↗InjuryDec 19, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. SURGEON REPORTED THAT POST-PRIMARY, STAFF ROTATED THE HIP WHILE MOVING THE PATIENT - THIS ROTATED THE STEM WITHIN THE PATIENT'S FEMUR, AND THE PATIENT SUBSEQUENTLY DISLOCATED THREE TIMES. SURGEON DECIDED TO PERFORM REVISION. THE STEM AND HEAD WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Inadequate Osseointegration
MAUDE report 23849215 ↗InjuryDec 10, 2025Osseointegration Problem; Osseointegration Problem
THE PATIENT HAD A REVISION PERFORMED ON HIM TO REVISE THE 7000-5506 INSIGNIA STEM DUE TO LOOSENING.
Patient problems: Inadequate Osseointegration
MAUDE report 23769380 ↗InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. AN INSIGNIA STEM AND CERAMIC HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND CERAMIC HEAD. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Bone Fracture(s)
MAUDE report 23720837 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
SURGEON SUSPECTED A LOOSE FEMORAL COMPONENT, REVISION SURGERY WAS PERFORMED AND THE DIAGNOSIS WAS CONFIRMED. HE PROCEEDED TO REVISE AN INSIGNIA STEM AND PUT IN A RESTORATION MODULAR STEM.
Patient problems: Inadequate Osseointegration
MAUDE report 23669978 ↗InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration
SURGEON SUSPECTED A LOOSE FEMORAL COMPONENT, REVISION SURGERY WAS PERFORMED AND THE DIAGNOSIS WAS CONFIRMED. HE PROCEEDED TO REVISE AN INSIGNIA STEM AND PUT IN A RESTORATION MODULAR STEM.
Patient problems: Inadequate Osseointegration
MAUDE report 23669975 ↗InjuryNov 17, 2025Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device
InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Other Howmedica Osteonics Corp. products
- Triathlon608 models · 3,524 reports · 15 recalls
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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