DJO SURGICAL 509-00-444Recalls & reported problems
Encore Medical, L.P. · RSP HUMERAL SOCKET INSERT, 44MM +4MM, STANDARD HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888912144605), received between Dec 28, 2017 and Mar 2, 2026 — classified as 18 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).
2 other recalls cover devices cleared under the same FDA submission (K141006); 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 Problem12
- Device Dislodged or Dislocated3
- Appropriate Device Problem Term/Code Not Available2
- Unstable2
- Detachment of Device or Device Component1
Patient problems
- Unspecified Infection8
- Joint Dislocation4
- Joint Laxity3
- Failure of Implant1
- No Code Available1
- Pain1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 24, 2026Device Dislodged or Dislocated
InjuryJan 30, 2026Device Dislodged or Dislocated
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS INFECTED, BUT STABLE. DR. WALKER REMOVED PREVIOUS REVISION IMPLANTS, WASHED OUT, AND PUT IN THE SAME SIZE OF NEW IMPLANTS
Patient problems: Unspecified Infection
MAUDE report 23834907 ↗InjuryJan 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
REVISION SURGERY DUE TO DISSOCIATION OF POLY FROM STEM.
Patient problems: Failure of Implant
MAUDE report 20909273 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION. COMPONENTS WERE REMOVED AND REPLACED WITH ABX SPACER. ABX SPACER REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 15165392 ↗InjuryNov 13, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INFECTION, SURGEON PERFORMED AN IRRIGATION AND DRAINAGE.
Patient problems: Unspecified Infection
MAUDE report 10836333 ↗InjuryJul 13, 2020Appropriate Device Problem Term/Code Not Available
InjuryDec 28, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT BEING NON-COMPLIANT AND DISLOCATING.
Patient problems: No Code Available
MAUDE report 7151771 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141006. One submission often covers many models, so check the product and lot details in each record.
- Z-3022-2020 · Aug 7, 2020 · Open, ClassifiedRSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
- Z-3021-2020 · Aug 7, 2020 · Open, ClassifiedRSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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