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DJO SURGICAL 520-46-124Recalls & reported problems

Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 46-24 · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912145190), received between Feb 15, 2016 and Apr 1, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available2
  • Adverse Event Without Identified Device or Use Problem1
  • Inadequacy of Device Shape and/or Size1
  • Torn Material1

Patient problems

  • No Code Available2
  • Joint Dislocation1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO DISLOCATION.

    Patient problems: Joint Dislocation

    MAUDE report 19016778 ↗
  • InjuryDec 22, 2021Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT PRESENTED SIX YEARS POST OPERATION FOLLOWING A REVISION SPACER. SURGEON DETERMINED THAT INFECTION WAS STILL PRESENT AND OPTED TO REVISE AGAIN. ALL PREVIOUS COMPONENTS WERE REMOVED AND NEW SPACER COMPONENTS WERE IMPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 13060333 ↗
  • InjuryAug 7, 2019Appropriate Device Problem Term/Code Not Available

    SECOND REVISION SURGERY - THE PATIENT WAS IN A LOT OF PAIN AND THE SURGEON WAS CONVERTING TO A TOURNIER REVERSE. NO DJO COMPONENTS WERE IMPLANTED.

    Patient problems: Pain

    MAUDE report 8871779 ↗
  • InjuryOct 27, 2017Torn Material

    REVISION SURGERY - DUE TO TORN ROTATOR CUFF; THE SURGEON TOOK OUT THE TURON COMPONENTS AND REPLACED WITH REVERSE SHOULDER PROSTHESIS COMPONENTS.

    Patient problems: No Code Available

    MAUDE report 6985360 ↗
  • InjuryFeb 15, 2016Inadequacy of Device Shape and/or Size

    REVISION SURGERY - DUE TO THE PATIENT REQUIRING A THINNER HEAD OPTION.

    Patient problems: No Code Available

    MAUDE report 5437251 ↗

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-0798-2011 · Nov 5, 2010 · Terminated
    Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
  • 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-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

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