DJO SURGICAL 411-00-035Recalls & reported problems
Encore Medical, L.P. · SLEEVE, UNIPOLAR, OFFSET -3.5 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912023412), received between Jan 6, 2017 and Jan 31, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Fracture1
Patient problems
- Joint Dislocation2
- Fall1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 13, 2020Detachment of Device or Device Component
REVISION SURGERY - FEMORAL HEAD DETACHED FROM THE STEM. REMOVED AND REPLACED THE SLEEVE.
Patient problems: No Code Available
MAUDE report 9830195 ↗InjuryFeb 6, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: SURGERY PERFORMED TO REVISE ACETABULAR COMPONENTS. PROXIMAL STEM GEOMETRY WAS FOUND TO BE NOTCHED. STEM REMOVAL PERFORMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9678457 ↗InjuryJan 12, 2018Appropriate Device Problem Term/Code Not Available
InjuryMay 1, 2017Fracture
REVISION SURGERY - DUE TO THE PATIENT HAVING FALLEN AND FRACTURING THEIR HIP. THE SURGEON REMOVED AND REPLACED THE ORIGINAL SLEEVE.
Patient problems: Fall
MAUDE report 6534752 ↗InjuryJan 6, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT'S HIP HAVING DISLOCATED, THEY REMOVED AND REPLACED ALL ORIGIONAL IMPLANTS.
Patient problems: Joint Dislocation
MAUDE report 6231124 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 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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