DJO SURGICAL 509-02-432Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 32MM NEUTRAL +4 Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical small socket insert for a shoulder replacement has 115 adverse event reports on file. Many describe joint dislocation, instability or looseness, and some describe infection requiring full removal or revision surgery. The reports include no deaths and 115 injuries, and no recalls name this device.
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
- 119
- Deaths reported
- 0
- Injuries reported
- 119
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 119 adverse event reports that list this exact device (DI 00190446257578), received between Jun 5, 2018 and Sep 21, 2026 — classified as 119 injuries.
The most frequently reported specific device problem is “Unstable” (24 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 Problem68
- Unstable24
- Appropriate Device Problem Term/Code Not Available19
- Device Dislodged or Dislocated17
- Loosening of Implant Not Related to Bone-Ingrowth2
- No Apparent Adverse Event2
- Failure to Align1
- Insufficient Device Problem Information1
Patient problems
- Joint Laxity30
- Joint Dislocation29
- Unspecified Infection29
- Insufficient Information9
- Implant Pain8
- Failure of Implant5
- Pain5
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 119 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50846802 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50796860 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50796859 ↗InjurySep 10, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50724616 ↗InjuryAug 28, 2026No Apparent Adverse Event
Revision surgery - Due to unknown revision reason / Poly Swap.
Patient problems: Insufficient Information
MAUDE report 50488560 ↗InjuryAug 5, 2026Device Dislodged or Dislocated
InjuryJun 24, 2026Unstable
InjuryJun 18, 2026Device Dislodged or Dislocated
InjuryMay 27, 2026Device Dislodged or Dislocated
InjuryMay 27, 2026Device Dislodged or Dislocated
InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY FULL REMOVAL DUE TO INFECTION. ENOVIS' IMPLANTS WERE REPLACED WITH SPACERS AND CEMENT.
Patient problems: Unspecified Infection
MAUDE report 25250364 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2026Unstable
InjuryMar 30, 2026Device Dislodged or Dislocated
InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 25, 2026Unstable; Adverse Event Without Identified Device or Use Problem
PATIENT WAS UNSTABLE, UPSIZED POLY FEMALE 73YRS.
Patient problems: Joint Laxity
MAUDE report 24445822 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryDec 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
InjuryDec 8, 2025Unstable; Unstable
PATIENT CLAIMED THEY FELT UNSTABLE, HOWEVER, THE DOCTOR ALSO MENTIONED THAT THE PT WAS A HEAVY DRINKER AND WAS PRONE TO FALLING. 55 YR OLD FEMALE.
Patient problems: Joint Laxity
MAUDE report 23743236 ↗InjuryNov 26, 2025Unstable; Unstable
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 4, 2025Unstable; Unstable
REVISION SURGERY - DUE TO INSTABILITY AND LOOSENING
Patient problems: Joint Laxity
MAUDE report 23472376 ↗
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
- 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
- GLOBAL UNITE 1100-12-100Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED1 recall29 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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