LFIT 06-3600Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327072365), received between Jul 24, 2019 and Jul 20, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Difficult to Setup or Prepare1
- Unstable1
Patient problems
- Injury1
- Joint Dislocation1
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2020Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S RIGHT TOTAL HIP WAS REVISED DUE TO INSTABILITY.
Patient problems: Injury; Joint Dislocation; Pain
MAUDE report 10294566 ↗MalfunctionJul 24, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
AS REPORTED: "SURGEON TRIED TO IMPLANT STEM AND IMPACT HEAD ONTO STEM. C-TAPER METAL HEAD DID NOT ENGAGE ONTO THE TRUNNION OF THE C-TAPER HFX STEM. HEAD JUST SPUN ON TRUNNION". A SURGICAL DELAY OF 5 MINUTES WAS REPORTED. A USAGE SHEET PROVIDED BY THE REP SHOWS A 36 +0 C-TAPER HEAD WITH "NO CHARGE", AND A 36 +2.5 C-TAPER HEAD WITH NO NOTE PLACED AFTERWARD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8821679 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page