DJO SURGICAL 509-03-040Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 40MM SEMI CONSTRAINED Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00190446257646), received between Sep 14, 2020 and Feb 12, 2025 — classified as 11 injuries.
The most frequently reported specific device problem is “Unstable” (4 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 Problem8
- Unstable4
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information1
Patient problems
- Joint Laxity4
- Unspecified Infection3
- Joint Dislocation2
- Failure of Implant1
- Medical device site infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT DISCLOCATED. TUBUEROSITY LOOKS TO HAVE RIPPED OUT AFTER SURGERY.
Patient problems: Joint Dislocation
MAUDE report 15908433 ↗InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15865052 ↗InjuryFeb 24, 2022Insufficient Device Problem Information
InjuryOct 4, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WOUND WOULD NOT HEAL AND GOT INFECTED. THE SURGEON HAD TO TAKE THE POLY OUT, WASH IT OUT AND REIMPLANT WITH NEW POLY.. THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 1 MONTH AND 3 WEEKS APART.
Patient problems: Unspecified Infection
MAUDE report 12573655 ↗InjuryJul 20, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INFECTION, IRRIGATION & DRAINAGE WITH INSERT EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 12199440 ↗InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10528945 ↗
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, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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