DJO SURGICAL 426-11-050Recalls & reported problems
Encore Medical, L.P. · HIP, STEM, CLP, LATERAL OFFSET, SIZE#5, IMPLANT, POLISHED NECK · 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 00888912079655), received between Oct 4, 2018 and Oct 15, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
1 other recall cover devices cleared under the same FDA submission (K052320); they may or may not involve this specific model.
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 Available1
- Loose or Intermittent Connection1
- Unintended Movement1
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - IMPLANT (FEMORAL STEM) WAS LOOSE, SURGEON EXPLANTED AND PUT IN ZIMMER REVISION STEM.
Patient problems: Insufficient Information
MAUDE report 10683742 ↗InjuryOct 4, 2018Unintended Movement
REVISION SURGERY - DUE TO THE 26 MILLIMETER STEM SUBSIDING. THE SURGEON REMOVED AND REPLACED WITH ANOTHER COMPANY. THE SURGEON PUT IN A NEW INSERT.
Patient problems: Failure of Implant
MAUDE report 7935468 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K052320. One submission often covers many models, so check the product and lot details in each record.
- Z-2605-2023 · Aug 4, 2023 · Open, ClassifiedDJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3, REF: 426-11-030
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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