Secur-Fit 1601-09132Recalls & reported problems
Howmedica Osteonics Corp. · 132 Degree Neck Angle V40 Hip Stem · Class 2 · Implant
All models of Secur-Fit (45)
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 07613327021349), received between Mar 20, 2017 and Dec 10, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
- Loss of Osseointegration1
- Migration1
- Migration or Expulsion of Device1
- Unintended Movement1
Patient problems
- Bone Fracture(s)2
- Injury2
- Pain2
- Fall1
- Hip Fracture1
- Inadequate Osseointegration1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Unintended Movement; Migration; Unintended Movement; Migration
SUBJECT SUSTAINED A FEMORAL FRACTURE AS A RESULT OF A FALL ON (B)(6)2022. ORIF WAS COMPLETED ON (B)(6)2022; SEE ATTACHED OPERATIVE NOTES AND ATTACHED CLINIC NOTES. SOME CONCERN OF FEMORAL SUBSIDENCE; FRACTURE HEALED AS OF (B)(6)2024. (NOTE THAT THE OPERATIVE NOTE HAS A DATE OF ORIGINAL SURGERY AS 2017 WHICH IS INCORRECT. SEE SUBSEQUENT FOLLOW-UP CLINIC NOTES CONFIRMING ORIGINAL SURGERY AS 2014.). SUBJECT WAS ENROLLED IN THE SECUR-FIT ADVANCE OUTCOMES STUDY 75.
Patient problems: Bone Fracture(s); Fall; Hip Fracture; Pain
MAUDE report 20897203 ↗InjuryApr 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "DR. PERFORMED REVISION HIP SURGERY. EXPLANTED SECUR-FIT STEM AND HEAD. REPLACED WITH RESTORATION STEM/ CONE BODY AND HEAD AND CABLES".
Patient problems: Insufficient Information
MAUDE report 14013926 ↗InjuryNov 19, 2020Loss of Osseointegration; Loss of Osseointegration
AS REPORTED: "STEM LOOSENED AND SUBSIDED. NOTHING FRACTURED. RIGHT SIDE. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. A SECUR-FIT ADVANCED STEM AND BIOLOX CERAMIC HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT AND NEW FEMORAL HEAD.
Patient problems: Inadequate Osseointegration
MAUDE report 10868016 ↗InjuryAug 24, 2017Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT A PATIENT, A STUDY SUBJECT IN THE TRIDENT II TRITANIUM POST-MARKET CLINICAL STUDY, STUMBLED WHILE WALKING DOWN STAIRS ON (B)(6) 2017 AND FELT A CRACK IN HER LEFT ANTERIOR THIGH. THE PATIENT SUFFERED IMMEDIATE PAIN AND WAS UNABLE TO WEIGHT-BEAR. THE PATIENT TOOK COUMADIN FOR PAIN MANAGEMENT. FOLLOW-UP AP PELVIS AND CROSS TABLE LATERAL X-RAYS SHOW THE FEMUR HAS SUBSIDED 22MM. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SPECIAL SURGERY FOR PAIN CONTROL PRIOR TO REVISION SURGERY. BASED ON THE EVENT DESCRIPTION THERE WAS A PERIPROSTHETIC FRACTURE. THE SHELL WAS UNAFFECTED AND WILL NOT REQUIRE REVISION. THE STEM SUBSIDED DUE TO THE FRACTURE.
Patient problems: Bone Fracture(s); Injury; Pain
MAUDE report 6818376 ↗InjuryMar 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
LEFT HIP REVISION DUE TO FAILED TOTAL HIP. UNSTABLE AND SUBSIDED. NO DELAY.
Patient problems: Injury
MAUDE report 6417258 ↗
Other Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous devices
- Accolade 6021-0537Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous46 reports
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- Accolade 6020-0335Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous35 reports
- OXINIUM 71342340Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous32 reports
- EXETER 0580-1-351Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous29 reports
- INSTRUMENT 2101-0200Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous27 reports
- REFLECTION 71330001Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous20 reports
- Accolade 6720-0330Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous18 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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