DJO SURGICAL 533-01-002Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, SMALL HEMI-ADAPTER · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00190446257714), received between Nov 5, 2020 and Sep 15, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Unstable” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Appropriate Device Problem Term/Code Not Available4
- Unstable1
Patient problems
- Insufficient Information3
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Failure of Implant1
- Joint Laxity1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO BROKEN IMPLANT AND PAIN.
Patient problems: Failure of Implant; Pain
MAUDE report 22891749 ↗InjuryFeb 5, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO HEMIARTHROPLASTY TO A REVERSE TOTAL SHOULDER.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12987028 ↗InjuryDec 9, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY : CONVERTED TO REVERSE, WAS A HEMI PRIOR.
Patient problems: Insufficient Information
MAUDE report 12968109 ↗InjuryDec 1, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO SHOULDER WAS CONVERTED FROM HEMI ARTHROPLASTY TO REVERSE TOTAL SHOULDER.
Patient problems: Insufficient Information
MAUDE report 10924896 ↗InjuryNov 5, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT PREVIOUSLY HAD A HEMI TOTAL SHOULDER IN AND NEEDED TO BE CONVERTED TO A REVERSE TOTAL SHOULDER ARTHROPLASTY. THE HUMERAL STEM WAS LEFT IN THE PATIENT AND THE HEAD AND ADAPTER WERE REMOVED. THE SURGEON THEN PRECEDED WITH A REVERSE TOTAL SHOULDER ARTHROPLASTY.
Patient problems: Insufficient Information
MAUDE report 10792958 ↗
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, ClassifiedRSP 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, ClassifiedDJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
- Z-0117-2021 · Aug 31, 2020 · TerminatedAltiVate 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 PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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