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DJO SURGICAL 520-42-116Recalls & reported problems

Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 42-16 · Class 2 · Implant

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

Adverse event reports
14
Deaths reported
0
Injuries reported
14
Recalls naming it
0

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912025027), received between Sep 28, 2015 and Aug 14, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 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: 1 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

  • Adverse Event Without Identified Device or Use Problem5
  • Appropriate Device Problem Term/Code Not Available5
  • Insufficient Device Problem Information1
  • Loose or Intermittent Connection1
  • Microbial Contamination of Device1
  • Unstable1

Patient problems

  • No Code Available3
  • Insufficient Information2
  • Unspecified Infection2
  • Fall1
  • Implant Pain1
  • Injury1
  • Joint Dislocation1
  • Joint Disorder1

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO WEAR.

    Patient problems: Joint Laxity

    MAUDE report 22812229 ↗
  • InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO PAIN.

    Patient problems: Implant Pain

    MAUDE report 18548490 ↗
  • InjuryAug 1, 2023Adverse 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 17438668 ↗
  • InjuryJan 11, 2022Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT FELL AND IT CAUSED INSTABILITY.

    Patient problems: Fall

    MAUDE report 13231502 ↗
  • InjuryJul 22, 2021Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PREVIOUS INFECTED SHOULDER WITH HEMI. CONVERTED HEMI TO TOTAL SHOULDER.

    Patient problems: Unspecified Infection

    MAUDE report 12213213 ↗
  • InjuryMay 20, 2021Appropriate Device Problem Term/Code Not Available

    SECOND REVISION SURGERY - POST OPERATION INSTABILITY.

    Patient problems: Insufficient Information

    MAUDE report 11858438 ↗
  • InjuryJan 25, 2021Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - HEAD EXCHANGE FOR INSTABILITY AND/OR HINGMENT.

    Patient problems: Insufficient Information

    MAUDE report 11225205 ↗
  • InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY: PUT GLENOID COMPONENT IN BECAUSE THE PATIENT PRESENTED PAIN.

    Patient problems: Pain

    MAUDE report 9208400 ↗
  • InjuryAug 24, 2018Microbial Contamination of Device

    SECOND REVISION SURGERY - DUE TO THE COMPONENTS BEING REMOVED IN AN ATTEMPT TO REVISE THE PATIENT TO A REVERSE TOTAL SHOULDER SINCE THE INFECTION WAS CLEANED UP. THE COMPONENTS WERE PLACE AS AN ANTIBIOTIC SPACER DURING A REVISION SURGERY.

    Patient problems: Unspecified Infection

    MAUDE report 7814352 ↗
  • InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO THE PATIENT HAVING A ROTATOR CUFF TEAR.

    Patient problems: Injury; No Code Available

    MAUDE report 7381134 ↗
  • InjuryNov 30, 2017Loose or Intermittent Connection

    REVISION SURGERY - DUE TO THE PATIENT HAVING ROTATOR CUFF ARTHROPATHY AND LOOSENING OF THE GLENOID COMPONENT. THE SURGEON CONVERTED THE TURON SHOULDER INTO A REVERSE SHOULDER.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7072353 ↗
  • InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - THE PATIENT RECEIVED AN ANATOMIC TOTAL SHOULDER ON (B)(6) 2015, HER ROTATOR CUFF HAS SINCE TORN. THE SURGEON WAS ABLE TO LEAVE THE ORIGINAL TURON STEM AND CONVERT HER TO A REVERSE SHOULDER.

    Patient problems: No Code Available

    MAUDE report 6254627 ↗
  • InjurySep 29, 2016Unstable

    REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE AND THE STEM HAVING SUBSIDED.

    Patient problems: No Code Available

    MAUDE report 5988841 ↗
  • InjurySep 28, 2015Insufficient Device Problem Information

    REVISION SURGERY - DUE TO THE PATIENT HAVING A NONFUNCTIONING ROTATOR CUFF. THE SURGEON EXCHANGED THE ORIGINAL NECK AND HEAD.

    Patient problems: Joint Disorder

    MAUDE report 5108757 ↗

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-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
  • Z-0799-2011 · Nov 5, 2010 · Terminated
    Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, 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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