DJO SURGICAL 509-02-040Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 40MM NEUTRAL Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00190446257639), received between Jul 17, 2019 and Apr 29, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Problem9
- Device Dislodged or Dislocated5
- Appropriate Device Problem Term/Code Not Available2
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- Joint Dislocation6
- Unspecified Infection5
- Joint Laxity2
- Failure of Implant1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Device Dislodged or Dislocated
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2021Appropriate Device Problem Term/Code Not Available
InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAS AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11380029 ↗InjuryDec 9, 2020Device Dislodged or Dislocated
REVISION SURGERY - DUE TO PATIENT DISLOCATED, REQUIRED REVISION.
Patient problems: Joint Dislocation
MAUDE report 10978836 ↗InjurySep 9, 2020Loose or Intermittent Connection; Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT WAS LOOSE AND DISLOCATED.
Patient problems: Failure of Implant
MAUDE report 10510195 ↗InjuryJun 10, 2020Device Dislodged or Dislocated
SECOND REVSION SUGERY - DUE TO DISLOCATION.
Patient problems: No Code Available
MAUDE report 10137803 ↗InjuryApr 9, 2020Device Dislodged or Dislocated
REVISION SURGERY - THE PATIENT WAS DISLOCATING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9943678 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem
THIRD REVISION SURGERY - PATIENT WAS INFECTED, CONVERTED TO ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 9118409 ↗InjuryAug 15, 2019Appropriate Device Problem Term/Code Not Available
InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY EXCHANGE DUE TO INFECTION WASH OUT.
Patient problems: Unspecified Infection
MAUDE report 8799532 ↗
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.
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