DJO SURGICAL 509-01-440Recalls & reported problems
Encore Medical, L.P. · RSP MONOBLOCK SOCKET INSERT, 40MM +4MM, SEMICONSTRAINED, HXE-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical reverse shoulder prosthesis component (a socket insert made by Encore Medical) has 23 adverse event reports, all involving injuries and no deaths. Reports mostly describe infections and joint instability or dislocation, often leading to revision surgery or removal of the implant. 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
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00888912144674), received between Feb 7, 2020 and Sep 23, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Unstable” (7 reports).
5 other recalls cover devices cleared under the same FDA submission (K051075); 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 Problem21
- Unstable7
- Device Dislodged or Dislocated2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Unspecified Infection12
- Joint Laxity8
- Joint Dislocation3
- Medical device site infection1
- No Code Available1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50862965 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
ALL IMPLANTS EXPLANTED AND ANTIBIOTIC SPACER IMPLANTED TO TREAT INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25461493 ↗InjuryApr 6, 2026Device Dislodged or Dislocated
InjuryMar 30, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 18145734 ↗InjuryNov 10, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PRESUMED INFECTION.
Patient problems: Medical device site infection
MAUDE report 15754876 ↗InjuryJun 8, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION AT SURGICAL SITE. REMOVED COMPONENTS, PERFORMED IRRIGATION & DRAINAGE AND PLACEMENT OF WOUND VAC. PLACEMENT OF ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 14634398 ↗InjuryFeb 7, 2020Device Dislodged or Dislocated
REVISION SURGERY: DISLOCATION. ADDED SPACER FOR STABILITY.
Patient problems: No Code Available
MAUDE report 9681596 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K051075. One submission often covers many models, so check the product and lot details in each record.
- Z-1460-2026 · Jan 15, 2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
- Z-0625-2024 · Oct 5, 2023 · CompletedReverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
- Z-0282-2024 · Sep 25, 2023 · Open, ClassifiedRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
- Z-2606-2023 · Aug 4, 2023 · Open, ClassifiedDJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder Syst
- Z-2739-2011 · Apr 18, 2011 · TerminatedReverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prost
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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