DJO SURGICAL 426-10-050Recalls & reported problems
Encore Medical, L.P. · HIP, STEM, CLP, STANDARD, SIZE#5, IMPLANT, POLISHED NECK · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912079532), received between Jan 3, 2018 and Oct 31, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bone Fracture(s)1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD A HIP FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 15701941 ↗InjuryJan 14, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT SUBSIDING AND THE STEM SINKING DOWN FURTHER.
Patient problems: No Code Available
MAUDE report 9588183 ↗InjuryOct 15, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - STEM WAS LOOSE SO ALL IMPLANTS WERE REMOVED AND REPLACED WITH STRYKER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9193603 ↗InjuryJan 3, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO LOOSE STEM. REVISED FOR PAIN. THE ACETABULAR CUP COMPONENTS WERE RETAINED. THE POLY INSERT WAS EXCHANGED.
Patient problems: Pain
MAUDE report 7160222 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 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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