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DJO SURGICAL 508-02-032Recalls & reported problems

Encore Medical, L.P. · ALTIVATE REVERSE, SMALL SOCKET INSERT, 32MM NEUTRAL · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446256908), received between Jun 4, 2020 and Apr 1, 2026 — classified as 7 injuries.

3 other recalls cover devices cleared under the same FDA submission (K172351); 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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 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: 1 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: 1 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 Available2

Patient problems

  • Joint Dislocation3
  • Unspecified Infection2
  • Medical device site infection1
  • No Code Available1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

    IENT DISLOCATED WITH ALTIVATE REVERSE SHOULDER PROSTHESIS IN PLACE PRIOR TO THE CASE. THE ATTEMPT WAS TO INCREASE CONSTRAINT TO LIMIT FUTURE DISLOCATIONS.

    Patient problems: Joint Dislocation

    MAUDE report 24754573 ↗
  • InjuryMay 16, 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 22040670 ↗
  • InjuryDec 15, 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 18341463 ↗
  • InjurySep 20, 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 17786467 ↗
  • InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - THE PATIENT WAS INFECTED. SURGEON DID A IRRIGATION & DRAINAGE AND REPLACED THE ITEMS.

    Patient problems: Medical device site infection

    MAUDE report 15663027 ↗
  • InjuryFeb 1, 2022Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO INFECTION. PULLED EVERYTHING TO PUT A ANTIBIOTIC SPACER.

    Patient problems: Unspecified Infection

    MAUDE report 13418185 ↗
  • InjuryJun 4, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - POST OPERATIVE INFECTION - NEEDED IRRIGATION & DRAINAGE AND POLY WAS SWAPPED.

    Patient problems: No Code Available

    MAUDE report 10118829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172351. One submission often covers many models, so check the product and lot details in each record.

  • Z-0281-2024 · Sep 25, 2023 · Open, Classified
    RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
  • Z-2607-2023 · Aug 4, 2023 · Open, Classified
    DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
  • Z-0117-2021 · Aug 31, 2020 · Terminated
    AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of

Other shoulder prosthesis, reverse configuration devices

All shoulder prosthesis, reverse configuration devices →

Sources and updates

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