DJO SURGICAL 411-00-146Recalls & reported problems
Encore Medical, L.P. · HEAD, UNIPOLAR, MODULAR, ENCORE SIZE46 · 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 00888912076814), received between May 12, 2020 and Jul 15, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 Dislodged or Dislocated2
Patient problems
- Insufficient Information1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - UNIPOLAR HEAD WAS NOT ATTACHED TO THE STEM. ORIGINAL STEM WAS LEFT IN PLACE. REMOVED AND EXCHANGED OUT THE UNIPOLAR THE BIPOLOR SHELL AND OFF SET SLEEVE TO FEMORAL HEAD.
Patient problems: Insufficient Information
MAUDE report 12177114 ↗InjuryJan 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INFECTION IS THE REASON FOR HEAD EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 11133585 ↗InjuryMay 12, 2020Device Dislodged or Dislocated
REVISION SURGERY - DUE TO PATIENT DISLOCATED.
Patient problems: No Code Available
MAUDE report 10048924 ↗
Other Prosthesis, Hip, Hemi-, Femoral, Metal devices
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- "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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