DJO SURGICAL 411-00-350Recalls & 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
- 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 00888912023429), received between Sep 21, 2020 and Sep 29, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Malposition of Device1
- Positioning Problem1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2020Positioning Problem
REVISION SURGERY - STEM COMPONENT SHIFTED TO RETRO VERSION AFTER REDUCING THE HIP OVER THE FEW DAYS OF PUTTING IT IN AND WAS DISLOCATING. SURGEON RE-BROACHED AND OUTED THE SAME STEM IN. ONLY TOOK OUT THE SLEEVE AND REPLACED WITH A NEW ONE.
Patient problems: No Code Available
MAUDE report 10600732 ↗InjurySep 21, 2020Malposition of Device; Device Dislodged or Dislocated
REVISION SURGERY - STEM COMPONENT SHIFTED TO RETRO VERSION AFTER REDUCING THE HIP OVER THE FEW DAYS OF PUTTING IT IN AND WAS DISLOCATING. SURGEON RE-BROACHED AND OUTED THE SAME STEM IN. ONLY TOOK OUT THE SLEEVE AND REPLACED WITH A NEW ONE.
Patient problems: No Code Available
MAUDE report 10560567 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page