DJO SURGICAL 509-03-032Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 32MM SEMI CONSTRAINED Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO reverse shoulder prosthesis was reported in 76 adverse event reports, including 76 injuries and no deaths. The reports mostly describe dislocation, unstable shoulders, infection, and revision surgery. There are no recalls naming this device identifier.
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
- 80
- Deaths reported
- 0
- Injuries reported
- 80
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00190446257561), received between Jun 7, 2018 and Sep 25, 2026 — classified as 80 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 Problem50
- Device Dislodged or Dislocated17
- Appropriate Device Problem Term/Code Not Available14
- Unstable4
- Insufficient Device Problem Information2
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- Unspecified Infection37
- Joint Dislocation14
- Insufficient Information10
- Joint Laxity9
- Failure of Implant3
- Pain3
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50905478 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50876512 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50812638 ↗InjurySep 15, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50781679 ↗InjuryMay 27, 2026Device Dislodged or Dislocated
InjuryMay 12, 2026Device Dislodged or Dislocated
InjuryMay 12, 2026Unstable
InjuryMay 6, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO LOSS OF RANGE OF MOTION.
Patient problems: Insufficient Information
MAUDE report 25107442 ↗InjuryApr 29, 2026Device Dislodged or Dislocated
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2026Unstable
InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT SHOWED SIGNS OF INFECTION. THE SURGEON ELECTED TO DO AN I&D AND REPLACE THE GLENOSPHERE AND THE HUMERAL BEARING AFTER WASHING OUT THE JOINT SPACE. FEMALE.
Patient problems: Unspecified Infection
MAUDE report 23752410 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, ALL IMPLANTS WERE EXPLANTED AND ANTIBIOTIC SPACER IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 23366107 ↗InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 27, 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
InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 29, 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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