DJO SURGICAL 533-10-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 10X108MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical Altivate Reverse humeral stem, a metal shoulder implant that sits uncemented in the upper arm bone. The 50 reports mostly describe the shoulder joint becoming unstable or the stem loosening in the bone, often leading to repeat surgery, with dislocation, infection and fracture also mentioned. There were 50 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00190446259152), received between Jun 22, 2018 and Jun 10, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Unstable” (8 reports).
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 Problem34
- Unstable8
- Loosening of Implant Not Related to Bone-Ingrowth5
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated2
- Loose or Intermittent Connection2
- Fracture1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Joint Laxity19
- Unspecified Infection11
- Joint Dislocation6
- Bone Fracture(s)4
- Limb Fracture4
- No Information3
- Pain3
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Unstable
InjuryMay 1, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO POTENTIAL STEM LOOSENING / INFECTION. FEMALE 73.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 25059308 ↗InjuryApr 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 1, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 21, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryDec 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 22655109 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 6, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND INFECTION
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21973469 ↗InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2024Mechanical Problem; Unstable; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO LOOSENING AND METALLOSIS.
Patient problems: Joint Laxity; Metal Related Pathology
MAUDE report 20921000 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION, FRACTURE AND LOOSENING.
Patient problems: Joint Dislocation; Joint Laxity; Limb Fracture
MAUDE report 19244728 ↗InjuryMay 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND INSTABILITY.
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 19244317 ↗InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNHEALED FRACTURE CAUSING A NONUNION IN THE HUMERUS. ORIGINAL CASE WAS A REVERSE FOR A FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 18718038 ↗InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT SUSTAINED A PERI PROSTHETIC HUMERUS FRACTURE RECENTLY WHICH DR. SCHEDULED A REVISION OF OF THE REVERSE SHOULDER AND ORIF OF THE HUMERAL FRACTURE. DR. REMOVED THE ALTIVATE SMALL SHELL SIZE 10 STEM AND +4 32MM SEMI CONSTRAINED INSERT. HE THEN IMPLANTED A SIZE 10 X 175 REVISION SMALL SHELL ALTIVATE REVERSE STEM, +8MM SPACER AND 32MM SEMI CONSTRAINED INSERT. HE FIXED THE HUMERAL FRACTURE WITH 2 CABLES APPROXIMATING THE HUMERAL FRAGMENTS AROUND THE STEM. ALL GLENOID COMPONENTS WERE RETAINED.
Patient problems: Insufficient Information; Limb Fracture
MAUDE report 18611232 ↗InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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