DJO SURGICAL 509-01-040Recalls & reported problems
Encore Medical, L.P. · RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 40MM, HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical reverse-configuration shoulder implant with a 40mm humeral socket insert. The 29 reports mostly describe shoulder instability and dislocation, infection at the implant site, and implants breaking or loosening, with several patients needing revision surgery; there were no deaths. All29 reports describe injuries. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888912144636), received between Jan 3, 2020 and Jun 24, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Unstable” (6 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 Problem22
- Unstable6
- Appropriate Device Problem Term/Code Not Available2
- No Apparent Adverse Event2
- Device Dislodged or Dislocated1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection15
- Joint Laxity6
- Joint Dislocation5
- Insufficient Information3
- Medical device site infection1
- Muscle/Tendon Damage1
- No Code Available1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryJun 24, 2026Device Dislodged or Dislocated
InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
PATIENT NEEDED TO BE WASHED OUT FROM OPENING UP THE WOUND, CAUSING A HEMATOMA.
Patient problems: Wound Dehiscence
MAUDE report 24879889 ↗InjuryMar 25, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 17, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISED TO TREAT INSTABILITY, SUSPECTED CASE WAS INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 23834942 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY, PAIN AND NUMBNESS.
Patient problems: Joint Laxity
MAUDE report 22040667 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND INSTABILITY.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21973508 ↗InjuryDec 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 7, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 2, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryMar 21, 2024No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY - DUE TO THE CAUSE OF THIS REVISION WAS TO PREVENT SOFT TISSUE DAMAGE OF THE DELTOID SIDE OF SHOULDER. THEREFORE, OUR HEMI ADAPTER AND 54X26N TURON HEAD WAS THE PLAY.
Patient problems: Insufficient Information
MAUDE report 18956388 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED POST-OPERATION OF REVISION OF REVERSE SHOULDER WITH INSTABILITY AND POTENTIAL SIGNS OF INFECTION. ORIGINALLY A ZIMMER SHOULD THAT WAS CONVERTED TO DJO/ZIMMER HYBRID. SURGEON HAS DETERMINED THAT A LARGER AUGMENT AND INSERT IS NEEDED.
Patient problems: Joint Laxity; Medical device site infection
MAUDE report 18218211 ↗InjuryNov 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE INFECTION AND FRACTURE.
Patient problems: Muscle/Tendon Damage; Unspecified Infection
MAUDE report 17484583 ↗InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse 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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