DJO SURGICAL 509-00-032Recalls & reported problems
Encore Medical, L.P. · RSP STANDARD HUMERAL SOCKET INSERT, 32MM, HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO reverse shoulder insert has 230 adverse event reports, including 228 injuries and no deaths. The reports mostly describe infections, the joint becoming unstable or dislocating, and patients needing revision surgery, with some describing the plastic part wearing down. 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
- 233
- Deaths reported
- 0
- Injuries reported
- 231
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00888912144537), received between Sep 24, 2015 and Sep 24, 2026 — classified as 231 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Unstable” (40 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 Problem122
- Appropriate Device Problem Term/Code Not Available43
- Unstable40
- Device Dislodged or Dislocated36
- Loose or Intermittent Connection10
- No Apparent Adverse Event3
- Inadequacy of Device Shape and/or Size2
- Naturally Worn2
Patient problems
- Unspecified Infection86
- Joint Laxity39
- Joint Dislocation31
- No Code Available27
- Insufficient Information18
- Failure of Implant12
- Pain7
- Implant Pain6
Recent adverse event reports
The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50891989 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50862963 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50812635 ↗InjurySep 17, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50812264 ↗InjuryAug 18, 2026No Apparent Adverse Event
Revision surgery - Due to unknown reason.
Patient problems: Insufficient Information
MAUDE report 50311022 ↗InjuryJul 27, 2026Unstable
InjuryJul 10, 2026Naturally Worn
InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 1, 2026Device Dislodged or Dislocated
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2026Unstable; Adverse Event Without Identified Device or Use Problem
THE SHOULDER WAS UNSTABLE SO THE GLENOID HEAD AND POLY WERE REMOVED AND REPLACED WITH 40MM COMPONENTS.
Patient problems: Joint Laxity
MAUDE report 24520808 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2026Unstable
InjuryJan 7, 2026Unstable
InjuryDec 19, 2025Unstable; Unstable
InjuryDec 16, 2025Unstable; Unstable
PATIENT WAS REVISED DUE TO SHOULDER INSTABILITY. MALE 54YRS.
Patient problems: Joint Laxity
MAUDE report 23824430 ↗InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY EXCHANGE, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23640764 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION, PAIN AND SWELLING.
Patient problems: Pain; Unspecified Infection
MAUDE report 23528626 ↗InjuryNov 5, 2025Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable
InjuryNov 3, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 23460067 ↗
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
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
- DJO SURGICAL 509-01-436Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall62 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.
How reports and recalls are matched · Editorial policy · Report an error on this page