DJO SURGICAL 509-03-440Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 40MM SEMI CONSTRAINED +4 Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00190446257660), received between May 22, 2020 and Jun 11, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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 Problem7
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Unstable1
Patient problems
- Joint Laxity4
- Joint Dislocation3
- Unspecified Infection3
- Medical device site infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Device Dislodged or Dislocated
InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND LOOSENING.
Patient problems: Unspecified Infection
MAUDE report 20511332 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 19823580 ↗InjuryOct 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - AFTER 2 SEQUENTIAL FALLS - PATIENT DISLOCATED REVERSE TOTAL SHOULDER AND WAS TAKEN TO THE OPERATING ROOM. UPON REVISION SURGERY IT WAS DISCOVERED THAT THE POLY DISASSOCIATED FROM THE HUMERAL STEM AND SPACER. IT WAS DETERMINED THAT POLY OVERHANG OVER THE STEM CAUSED THE INSERT TO DISASSOCIATE AND THEM LATER DISLOCATE OFF THE STEM.
Patient problems: Joint Laxity
MAUDE report 18026734 ↗InjuryOct 4, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISSOCIATION AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17187747 ↗InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT BECAME INFECTED POST OPERATION.
Patient problems: Medical device site infection
MAUDE report 16015384 ↗InjuryMay 22, 2020Appropriate Device Problem Term/Code Not Available
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.
How reports and recalls are matched · Editorial policy · Report an error on this page