Secur-Fit 1601-08132Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327021325), received between Apr 20, 2018 and Nov 2, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 Information3
- Degraded1
Patient problems
- Bone Fracture(s)3
- Injury3
- Fall1
- Foreign Body Reaction1
- Metal Related Pathology1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2023Degraded; Degraded
IT IS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT LEFT THA ON (B)(6) 2015, AND WAS IMPLANTED WITH A SECUR-FIT ADVANCED HIP STEM AND A LFIT ANATOMIC V40 FEMORAL HEAD. HE WAS REVISED ON (B)(6) 2021 ALLEGEDLY DUE TO PAIN, ELEVATED METAL ION LEVELS, AND METALLOSIS AT THE HEAD-TRUNNION INTERFACE.
Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain
MAUDE report 18054163 ↗InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "RIGHT HIP FEMORAL FRACTURE. CABLED FEMUR AND EXCHANGED FEMORAL STEM".
Patient problems: Bone Fracture(s); Injury
MAUDE report 8738834 ↗InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL. A SECUR-FIT ADVANCED STEM, 36 +0 BIOLOX CERAMIC HEAD, AND 36E POLY LINER WERE REVISED TO AN ADM/MDM LINER CONSTRUCT WITH A COMPETITOR STEM AND HEAD. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Bone Fracture(s); Fall; Injury
MAUDE report 8457752 ↗InjuryApr 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
AS REPORTED: "[PATIENT] HAD...HIP REPLACED (B)(6) 2018. [PATIENT] HAD A FRACTURE OF HER MEDIAL CALCAR POST-OP. [SURGEON] REVISED...TO A RESTORATION MODULAR". OPERATIVE SIDE IS LEFT.
Patient problems: Bone Fracture(s); Injury
MAUDE report 7447591 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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