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DJO SURGICAL 520-38-014Recalls & reported problems

Encore Medical, L.P. · HEAD, HUMERAL, NEUTRAL, 38-14 · 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 00888912024983), received between Apr 20, 2016 and Mar 15, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K080402); 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
  • Device Dislodged or Dislocated1
  • Device Operates Differently Than Expected1
  • Loose or Intermittent Connection1

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.

  • InjuryMar 15, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT WAS HAVING A LOOSE AND UNSTABLE SHOULDER, CONVERTED FROM A HEMI TO AN REVERSE SHOULDER PROSTHESIS.

    Patient problems: Insufficient Information

    MAUDE report 13775080 ↗
  • InjuryFeb 9, 2017Device Operates Differently Than Expected

    REVISION SURGERY - THE SURGEON PUT IN A HOMEMADE SPACER BECAUSE THE PATIENT HAD AN INFECTION, HE REMOVED THE HEAD AND ADAPTOR AND COMPLETED THE REVERSE SHOULDER PROSTHESIS SURGERY.

    Patient problems: Unspecified Infection

    MAUDE report 6315984 ↗
  • InjuryApr 20, 2016Device Dislodged or Dislocated

    REVISION SURGERY - DUE TO THE PATIENT'S JOINT DISLOCATING.

    Patient problems: No Code Available

    MAUDE report 5592456 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080402. One submission often covers many models, so check the product and lot details in each record.

  • Z-0800-2011 · Nov 5, 2010 · Terminated
    Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
  • Z-0799-2011 · Nov 5, 2010 · Terminated
    Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
  • Z-0798-2011 · Nov 5, 2010 · Terminated
    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
  • Z-0801-2011 · Nov 5, 2010 · Terminated
    Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical

Other Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices

All Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page