DJO SURGICAL 509-02-436Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 36MM NEUTRAL +4 Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a shoulder implant made by Encore Medical, a metal-on-plug replacement for the ball-and-socket joint. Most of the 54 reports describe the shoulder joint repeatedly dislocating or feeling unstable, with the plastic socket piece coming apart from the stem, and several patients needing revision surgery; others mention infection, pain, and reduced movement. There are no deaths, and 54 injuries. 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
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00190446257615), received between Aug 1, 2019 and Apr 22, 2026 — classified as 54 injuries.
The most frequently reported specific device problem is “Unstable” (9 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 Problem39
- Unstable9
- Device Dislodged or Dislocated6
- Appropriate Device Problem Term/Code Not Available5
- Break1
- Fracture1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Dislocation17
- Joint Laxity17
- Unspecified Infection9
- Failure of Implant4
- Implant Pain4
- Insufficient Information3
- Loss of Range of Motion3
- Medical device site infection2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT WAS CHRONICALLY DISLOCATING THEIR RSA. AFTER INCISION IT WAS FOUND THE POLY HAD DISASSOCIATED FROM THE STEM.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24961031 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 18, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION AND DISASSOCIATED.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24384463 ↗InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24031326 ↗InjuryOct 22, 2025Off-Label Use; Off-Label Use
IT WAS REPORTED THAT THE PATIENT'S REQUIRED REVISION SURGERY DUE TO FAILURE OF GLENOID COMPONENT, DIFFERENT COMPANY.
Patient problems: Insufficient Information
MAUDE report 23356077 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PATIENT COMPLAINED OF TIGHTNESS IN SHOULDER. PLAN WAS TO REMOVE ANY ADHESIONS AND READDRESS TENSION.
Patient problems: Loss of Range of Motion
MAUDE report 22216175 ↗InjuryMay 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED TO DOCTOR OFFICE WITH INFLAMMATION IN PREVIOUS REVISED SHOULDER. DOCTOR DID A COMPONENT EXCHANGE WITH THE ADDITION OF A SPACER.
Patient problems: Swelling/ Edema
MAUDE report 22007082 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PREVIOUSLY HAD AN APC, STILL EXPERIENCING PAIN DID A POLY AND GLENOSPHERE SWAP.
Patient problems: Implant Pain
MAUDE report 20424269 ↗InjuryAug 9, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
RIVISION SURGERY - DUE TO DISLOCATION, INSTABILITY AND PAIN.
Patient problems: Implant Pain; Joint Dislocation; Joint Laxity
MAUDE report 19495034 ↗InjuryJun 4, 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
InjuryApr 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION & INSTABILITY.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19102521 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT COMPLAINED OF TIGHT SHOULDER.
Patient problems: Loss of Range of Motion
MAUDE report 18874130 ↗InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - DISLOCATION - PATIENT DISLOCATED SHOULDER AND LEFT IT DISLOCATED FOR MONTHS. POLY INSERT WAS DISLODGED FROM STEM.
Patient problems: Joint Dislocation
MAUDE report 18531951 ↗InjuryDec 21, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 18378926 ↗InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - SIGNIFICANT ADVERSE EVENT/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE (REVISION).
Patient problems: Failure of Implant
MAUDE report 18213158 ↗
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, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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