DJO SURGICAL 508-00-036Recalls & reported problems
Encore Medical, L.P. · SOCKET, INSERT 36MM STD. RSP HUMERAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical reverse-configuration shoulder prosthesis insert (socket, 36mm standard humeral). The 56 reports describe the shoulder implant becoming unstable or dislocating, along with infections and fractures, with several patients needing revision surgery. All 56 reports involve injuries and there are 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
- 56
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00888912024655), received between Sep 29, 2015 and Jan 19, 2026 — classified as 56 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 Problem15
- Appropriate Device Problem Term/Code Not Available12
- Device Dislodged or Dislocated12
- Unstable12
- Fracture3
- Insufficient Device Problem Information3
- Device Operates Differently Than Expected2
- Loose or Intermittent Connection2
Patient problems
- Unspecified Infection18
- No Code Available12
- Joint Laxity6
- Failure of Implant5
- Bone Fracture(s)4
- No Known Impact Or Consequence To Patient4
- Joint Dislocation3
- Fall2
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2026Unstable
InjuryJan 14, 2026Device Dislodged or Dislocated
InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS FEELING PAIN.
Patient problems: Implant Pain
MAUDE report 19465200 ↗InjuryApr 30, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2024Unstable; 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
MAUDE report 19149673 ↗InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO OSTEOLYSIS AND BASEPLATE FRACTURE.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 15322168 ↗InjuryAug 23, 2022Insufficient Device Problem Information
InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15157180 ↗InjuryJul 18, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS FEELING DISCOMFORT. SURGEON CLEANED OUT SOME TISSUE AND REPLACED THE HUMERAL SOCKET INSERT.
Patient problems: Discomfort
MAUDE report 15048341 ↗InjuryMay 4, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO STABILITY ISSUE GLENOSPHERE AND POLY REMOVED.
Patient problems: Insufficient Information
MAUDE report 14273744 ↗InjuryFeb 25, 2022Appropriate Device Problem Term/Code Not Available
InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO SHOULDER WAS LOOSE AND NOT LATERALIZED ENOUGH.
Patient problems: Joint Laxity
MAUDE report 12882827 ↗InjuryMay 28, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS EXPERIENCING POST-OPERATIVE INSTABILITY AND PAIN.
Patient problems: Pain
MAUDE report 11901606 ↗InjuryMay 14, 2021Unstable
REVISION SURGERY - PATIENT'S SHOULDER WAS DISLOCATED HAD OVERALL INSTABILITY ISSUES WERE PRESENT. REVISION SURGERY WAS REQUIRED TO PROVIDE MORE STABLE CONSTRUCT.
Patient problems: Failure of Implant
MAUDE report 11829535 ↗InjuryMay 5, 2021Unstable
REVISION SURGERY - PATIENT SHOULDER BECAME UNSTABLE, A THICKER POLY WAS INSERTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11776858 ↗InjuryNov 18, 2020Fracture
REVISION SURGERY - DUE TO PATIENT HAVING AN INFECTION AND A FRACTURE. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER (NOT DJO PRODUCT) / PROSTHESIS WAS IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 10862926 ↗InjuryOct 27, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT WAS GROSSLY INFECTED. SURGEON REMOVED ALL COMPONENTS AND PLACED A BIOMET ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 10743413 ↗InjuryOct 22, 2020Fracture
REVISION SURGERY - PATIENT HAD AN INFECTION AND FRACTURE. ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER / PROSTHESIS WAS IMPLANTED.
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 10719172 ↗InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAS AN INFECTION. ALL COMPONENTS WERE REMOVED AND NO NEW COMPONENTS WERE IMPLANTED AT THIS TIME.
Patient problems: Unspecified Infection
MAUDE report 10671332 ↗InjuryJun 30, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10212134 ↗InjuryJun 25, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED, SO SURGEON REVISED PATIENT WITH A THICKER INSERT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10195563 ↗
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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