DJO SURGICAL 411-00-000Recalls & reported problems
Encore Medical, L.P. · SLEEVE, UNIPOLAR, OFFSET NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912076692), received between Nov 11, 2016 and May 17, 2018 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- No Code Available1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FEELING PAIN. DURING THE SURGERY, THE SURGEON FOUND NOTHING HE THOUGHT COULD BE CAUSING IT. THE SURGEON REPLACED 3 OF THE IMPLANTS.
Patient problems: Pain
MAUDE report 7522573 ↗InjuryNov 8, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT BEING REVISED FROM A HEMI HIP TO A TOTAL HIP. THE UNIPOLAR HEAD WAS REMOVED AND THE TAPERFILL STEM WAS WELL FIXED AND RETAINED.
Patient problems: No Code Available
MAUDE report 7010088 ↗InjuryNov 11, 2016Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING AN ACUTE INFECTION; THE SURGEON REMOVED AND REPLACED THE LINER HEAD AND SLEEVE.
Patient problems: Unspecified Infection
MAUDE report 6096746 ↗
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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