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DJO SURGICAL 520-14-000Recalls & reported problems

Encore Medical, L.P. · AltiVate Anatomic, Short Humeral Stem, 14mm · 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 00190446176039), received between Dec 4, 2017 and May 7, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K162024); 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: 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: 1 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
  • Device Dislodged or Dislocated2
  • Adverse Event Without Identified Device or Use Problem1
  • Patient-Device Incompatibility1
  • Torn Material1

Patient problems

  • Fall1
  • Joint Dislocation1
  • No Code Available1
  • 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.

  • InjuryMay 7, 2026Device Dislodged or Dislocated

    REVISION SURGERY DUE TO DISLOCATION.

    Patient problems: Joint Dislocation

    MAUDE report 25119728 ↗
  • InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 22929629 ↗
  • InjuryMay 20, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT FELL AND DISLOCATED. SHE HAD AN ANATOMIC SHOULDER REPLACEMENT. SURGEON WANTED TO CONVERT TO A REVERSE SHOULDER BECAUSE PATIENT HAD NO CUFF.

    Patient problems: Fall

    MAUDE report 11858448 ↗
  • InjuryNov 13, 2020Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT PRESENTED SHOULDER PAIN. REMOVED AND EXCHANGED ALL IMPLANTS EXCEPT FOR THE GLENOID.

    Patient problems: Pain

    MAUDE report 10836328 ↗
  • InjuryDec 4, 2017Torn Material

    REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH A TORN SUBSCAP REPAIR STATUS POST OPERATION OF A TOTAL SHOULDER. THE SURGEON DECIDED TO GO IN AND REPLACE ALL THE IMPLANTS FROM THE TOTAL SHOULDER AND DO A REVERSE SHOULDER.

    Patient problems: No Code Available

    MAUDE report 7080377 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162024. One submission often covers many models, so check the product and lot details in each record.

  • Z-2331-2021 · Jun 28, 2021 · Open, Classified
    AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16
  • Z-1256-2018 · Jan 29, 2018 · Completed
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
  • Z-1259-2018 · Jan 29, 2018 · Completed
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
  • Z-1260-2018 · Jan 29, 2018 · Completed
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated
  • Z-1258-2018 · Jan 29, 2018 · Completed
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
  • Z-1257-2018 · Jan 29, 2018 · Completed
    Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as

Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices

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Sources and updates

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