LFIT 06-3610Recalls & reported problems
Howmedica Osteonics Corp. · Femoral Head · Class 2 · Implant
All models of LFIT (23)
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 07613327072372), received between May 24, 2021 and Sep 15, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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.
Most reported problems
Device problems
- Device-Device Incompatibility1
- Unstable1
Patient problems
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2022Unstable; Unstable
REVISED LEFT HIP CUP, LINER AND HEAD DUE TO INSTABILITY. THIS TIME, THE PATIENT WAS CHANGED TO CONSTRAINED LINER WITH MULTI-HOLE CUP. NO ALLEGATIONS MADE AGAINST THE IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 15425685 ↗InjuryMay 24, 2021Device-Device Incompatibility; Device-Device Incompatibility
BROUGHT PT TO OPERATING ROOM TO CHANGE FEM. HEAD. UPDATE 28/APRIL/2021 (B)(4): SPOKE TO REP. IN REVISING THE PATIENT'S HIP DUE TO A PERCEIVED LIMB LENGTH DISCREPANCY, A 32+0 FEMORAL HEAD WAS REVISED TO A 36 +10 FEMORAL HEAD. POST-OPERATIVELY, DISCOVERY WAS MADE THAT THE 36MM HEAD HAD BEEN IMPLANTED INTO A LINER WITH INNER DIAMETER OF 32MM. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND THE HEAD AND SLEEVE WERE EXCHANGED FOR THE APPROPRIATE SIZE.
Patient problems: Insufficient Information
MAUDE report 11870820 ↗
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 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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