DJO SURGICAL 509-02-440Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 40MM NEUTRAL +4 Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00190446257653), received between Feb 7, 2019 and May 18, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 Problem5
- Device Dislodged or Dislocated3
- Unstable3
Patient problems
- Joint Laxity4
- Joint Dislocation3
- Unspecified Infection3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Device Dislodged or Dislocated
REVISION SURGERY DUE TO SHOULDER KEEPS DISLOCATING.
Patient problems: Joint Dislocation
MAUDE report 25211559 ↗InjuryApr 29, 2026Unstable
InjuryMar 23, 2026Unstable
InjuryFeb 26, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION AND DISASSOCIATED.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24464918 ↗InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WITH SIGNIFICANT REVISION REVERSE TOTAL SHOULDER HISTORY HAD AN ALLOGRAFT/PROTHESIS COMPOSITE RECONSTRUCTION ON THE HUMERAL SIDE DUE TO PROXIMAL BONE LOSS. HOWEVER PATIENT WAS STILL HAVING A SIGNIFICANT NUMBER OF DISLOCATION EVENTS. INTRAOPERATIVELY THE PATIENT WAS FOUND TO HAVE SIGNIFICANT RETROVERSION OF THE WELL FIXED HUMERAL COMPONENT AND THE GLENOID COMPONENT WAS FOUND TO BE WELL FIXED AS WELL. A 12MM SPACER AND +4 POLY WAS ADDED THE HUMERAL COMPONENT TO HOPEFULLY MAKE THE PATIENT STABLE LONG TERM.
Patient problems: Joint Dislocation
MAUDE report 18213146 ↗InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD BLOOD COOLING THAT WAS SETTING UP FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15104331 ↗InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: PATIENT WAS INFECTED SO SURGEON HAD TO DO AN IRRIGATION AND DEBARMENT.
Patient problems: Unspecified Infection
MAUDE report 9431409 ↗InjuryFeb 7, 2019Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO INSTABILITY AND DISLOCATION. THE SURGEON NEED TO INCREASE POLY FOR INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8317314 ↗
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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