DJO SURGICAL 509-03-036Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 36MM SEMI CONSTRAINED Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical shoulder implant (a metal hemi prosthesis with a small socket insert) is used to replace part of the shoulder joint. The 33 reports describe shoulder instability, dislocation of the implant, and infection, with many patients needing revision surgery; no deaths were reported, and all 33 reports involve injuries. There are no recalls naming this device. Reports rose from 4 in the previous 12 months to 7 in the most recent 12 months.
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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00190446257608), received between Dec 5, 2019 and Sep 15, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Problem20
- Device Dislodged or Dislocated6
- Unstable6
- Appropriate Device Problem Term/Code Not Available5
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection16
- Joint Dislocation10
- Joint Laxity5
- Failure of Implant2
- Medical device site infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Discomfort1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Patient Device Interaction Problem
InjurySep 1, 2026Device Dislodged or Dislocated
InjuryJun 17, 2026Unstable
InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2026Device Dislodged or Dislocated
InjuryJun 3, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 25369531 ↗InjuryMay 27, 2026Device Dislodged or Dislocated
InjuryJan 19, 2026Unstable
InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 19, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 20575202 ↗InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THIS WAS A REVISION OF A HYBRID DJO AND BIOMET SHOULDER. DJO STEM AND POLLY. BIOMET GLENOID. THE GLENOID FAILED. DR. UPSIZED THE BIOMET GLENOSPHERE TO A SIZE 40. WE PUT IN A 40 SMALL SOCKET SEMI CONSTRAINED +4. FEMALE, 74.
Patient problems: Failure of Implant
MAUDE report 18785238 ↗InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 16219348 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page