DJO SURGICAL 509-02-032Recalls & reported problems
Encore Medical, L.P. · AR, SMALL SOCKET INSERT, 32MM NEUTRAL Eplus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO partial shoulder implant is a metal joint replacement part. The 355 reports describe infection, dislocation and joint instability, and some describe repeat surgery. The reports record 354 injuries, 1 malfunction and no deaths. 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
- 364
- Deaths reported
- 0
- Injuries reported
- 363
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 364 adverse event reports that list this exact device (DI 00190446257554), received between May 17, 2018 and Sep 28, 2026 — classified as 363 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unstable” (58 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 Problem215
- Appropriate Device Problem Term/Code Not Available76
- Unstable58
- Device Dislodged or Dislocated48
- Patient Device Interaction Problem4
- Loose or Intermittent Connection3
- Fracture2
- Insufficient Device Problem Information2
Patient problems
- Unspecified Infection120
- Joint Dislocation75
- Joint Laxity65
- Insufficient Information23
- Implant Pain18
- Pain15
- Medical device site infection13
- No Code Available11
Recent adverse event reports
The 25 most recent of 364 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50926528 ↗InjurySep 21, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50849240 ↗InjurySep 21, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50849237 ↗InjurySep 16, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50796561 ↗InjurySep 15, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50782325 ↗InjurySep 15, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50781683 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
InjurySep 14, 2026Fracture; Device Dislodged or Dislocated
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 50765483 ↗InjurySep 11, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50725173 ↗InjurySep 1, 2026Device Dislodged or Dislocated
InjuryAug 17, 2026Device Dislodged or Dislocated
InjuryJul 10, 2026Unstable
InjuryJun 24, 2026Unstable
InjuryJun 24, 2026Device Dislodged or Dislocated
InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
ALL IMPLANTS REMOVED FROM CASE IN 2022 BY (B)(6) AT (B)(6) HOSPITAL IN (B)(6) DUE TO POTENTIAL INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25461504 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD PAIN AND HAD LOSS OF RANGE OF MOTION.
Patient problems: Implant Pain; Loss of Range of Motion
MAUDE report 25429202 ↗InjuryJun 5, 2026Unstable
InjuryJun 3, 2026Patient Device Interaction Problem
REVISION SURGERY - THE SHOULDER WAS TIGHT, SO DOCTOR WANTED TO DO A HEAD AND POLY EXCHANGE. HEAD LOOKED GOOD SO WE JUST DID POLY.
Patient problems: Loss of Range of Motion
MAUDE report 25369533 ↗InjuryMay 29, 2026Unstable
InjuryMay 29, 2026Unstable
InjuryMay 26, 2026Device Dislodged or Dislocated
InjuryMay 25, 2026Unstable
InjuryMay 12, 2026Adverse 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 PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- 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
- 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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