DJO SURGICAL 509-03-436Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 36MM SEMI CONSTRAINED +4 Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical shoulder implant is a metal, uncemented partial shoulder replacement used to rebuild the shoulder's ball-and-socket joint. The 34 reports describe the implant dislocating or slipping out of place, the joint becoming loose, and infections, with 34 injuries and no deaths; several patients needed revision surgery to fix a dislocated or loosened implant. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 37
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00190446257622), received between Sep 6, 2019 and Sep 17, 2026 — classified as 37 injuries.
The most frequently reported specific device problem is “Unstable” (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 Problem23
- Unstable6
- Device Dislodged or Dislocated4
- Appropriate Device Problem Term/Code Not Available3
- No Apparent Adverse Event2
- Patient Device Interaction Problem2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection14
- Joint Dislocation9
- Joint Laxity9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Implant Pain1
- Insufficient Information1
- Loss of Range of Motion1
- No Code Available1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50812637 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50812631 ↗InjurySep 2, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50554782 ↗InjuryJun 22, 2026Device Dislodged or Dislocated
InjuryJun 3, 2026Unstable
InjuryJun 3, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO RECURRING DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 25369538 ↗InjuryMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 7, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PATIENT WAS STIFF WITH BAD RANGE OF MOTION.
Patient problems: Loss of Range of Motion
MAUDE report 25119780 ↗InjuryApr 7, 2026Device Dislodged or Dislocated
InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
POST OP PAIN DEVELOPED AFTER SEVERAL YEARS. DR. REMOVED THE POLY AND GLENOSPHERE TO PERFORM SOFT TISSUE RELEASES. IMPLANTED NEW POLY AND GLENOSPHERE.
Patient problems: Pain
MAUDE report 23763925 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 31, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND DISSOCIATED.
Patient problems: Joint Laxity
MAUDE report 21050489 ↗InjuryDec 26, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 9, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 13, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryApr 3, 2024Adverse 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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