DJO SURGICAL 509-02-036Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 36MM NEUTRAL Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical reverse shoulder insert is a plastic socket insert used in shoulder replacement. Its 104 reports, all injury reports, often describe patients with dislocations, instability or infections, and many of the reports describe revision surgery. There were no deaths, and 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
- 108
- Deaths reported
- 0
- Injuries reported
- 108
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00190446257592), received between Jan 23, 2019 and Sep 25, 2026 — classified as 108 injuries.
The most frequently reported specific device problem is “Unstable” (15 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 Problem67
- Appropriate Device Problem Term/Code Not Available25
- Unstable15
- Device Dislodged or Dislocated10
- Loosening of Implant Not Related to Bone-Ingrowth2
- Crack1
- Loose or Intermittent Connection1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection43
- Joint Dislocation29
- Joint Laxity20
- Insufficient Information7
- Loss of Range of Motion4
- Medical device site infection3
- No Known Impact Or Consequence To Patient3
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 108 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50892496 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50862970 ↗InjurySep 15, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50781674 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 22, 2026Device Dislodged or Dislocated
InjuryMay 27, 2026Unstable
InjuryMay 26, 2026Unstable
InjuryMay 15, 2026Device Dislodged or Dislocated
InjuryMay 7, 2026Device Dislodged or Dislocated
InjuryApr 24, 2026Device Dislodged or Dislocated
InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO POLY SWAP DURING WASHOUT OF SUPERFICIAL INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24933741 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2026Unstable
PT PRESENTED TO DR OFFICE DISLOCATED. DR. (B)(6) DECIDED TO UPSIZE THE POLY TO CORRECT THIS ISSUE.
Patient problems: Joint Dislocation
MAUDE report 24631343 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO BASEPLATE FAILURE AND LOOSENING.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 24000041 ↗InjuryDec 19, 2025Unstable; Unstable
InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23418420 ↗InjuryOct 26, 2025Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 23388093 ↗InjurySep 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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
InjuryAug 7, 2025Adverse 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 shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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