DJO SURGICAL 509-01-036Recalls & reported problems
Encore Medical, L.P. · RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 36MM, HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical reverse-configuration shoulder prosthesis is a humeral socket insert used in shoulder replacement surgery. The 76 reports mostly describe infection around the implant and instability of the joint, with dislocation, laxity and pain also mentioned, and several patients needing revision surgery to remove or replace components. All 76 reports describe injuries, with 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
- 79
- Deaths reported
- 0
- Injuries reported
- 79
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 00888912144629), received between Mar 15, 2017 and Sep 23, 2026 — classified as 79 injuries.
The most frequently reported specific device problem is “Unstable” (15 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 Problem45
- Appropriate Device Problem Term/Code Not Available17
- Unstable15
- Device Dislodged or Dislocated8
- Loose or Intermittent Connection2
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection39
- Joint Laxity13
- Joint Dislocation6
- No Code Available6
- Implant Pain4
- Pain4
- Insufficient Information3
- Failure of Implant2
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50876064 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50812634 ↗InjuryAug 5, 2026Device Dislodged or Dislocated
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
PATIENT DEVELOPED PJI. DR. (B)(6) REMOVED ALL COMPONENTS EXCEPT FOR WELL FIXED BASEPLATE AND STEM TO PERFORM I&D. REPLACED IMPLANTS WITH NEW.
Patient problems: Unspecified Infection
MAUDE report 25461488 ↗InjuryJun 9, 2026Device Dislodged or Dislocated
InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 14, 2026Unstable
InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 29, 2026Unstable
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
SUSPECTED SHOULDER INFECTION. 66 YR OLD MALE.
Patient problems: Unspecified Infection
MAUDE report 24721009 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND INSTABILITY.
Patient problems: Unspecified Infection
MAUDE report 24678168 ↗InjuryMar 20, 2026Device Dislodged or Dislocated
InjuryMar 12, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PATIENTED PRESENTET POST OP WITH COMPLAINTS OF PAIN. SURGEON OPTED TO REVISE AND REMOVE SOME COMPONENTS.
Patient problems: Pain
MAUDE report 24580341 ↗InjuryMar 5, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 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
InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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