DJO SURGICAL 509-01-444Recalls & reported problems
Encore Medical, L.P. · RSP MONOBLOCK SOCKET INSERT, 44MM +4MM, SEMICONSTRAINED, HXE-PLUS · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912144681), received between Jul 18, 2019 and Sep 15, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 Problem6
- Appropriate Device Problem Term/Code Not Available5
- Device Dislodged or Dislocated4
- Unstable3
Patient problems
- Unspecified Infection9
- Joint Dislocation5
- Insufficient Information2
- Joint Laxity2
- Failure of Implant1
- Medical device site infection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Dislocation
MAUDE report 50782326 ↗InjurySep 11, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 50725168 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 15, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO INSTABILITY AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24891962 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2025Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY TO TREAT INSTABILITY AND POSSIBLE INFECTION.
Patient problems: Joint Dislocation; Joint Laxity; Unspecified Infection
MAUDE report 23353647 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15607919 ↗InjuryOct 22, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED. LIKELY CAUSE, ACCORDING TO SURGEON WAS THE HUMERAL SIDE WAS NOT BUILT LONG ENOUGH TO PROVIDE SUFFICIENT DELTOID TENSION. THE ADDITION OF AN 8MM SPACER, NEW GLENOSPHERE AND HUMERAL SOCKET INSERT WERE IMPLANTED TO INCREASE DELTOID TENSION DURING THE REVISION PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 12686424 ↗InjuryOct 21, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12678267 ↗InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY ,PATIENT WAS DISLOCATED AND POSSIBLY INFECTED.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 12439738 ↗InjuryAug 3, 2021Appropriate Device Problem Term/Code Not Available
InjuryApr 30, 2021Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY: DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11758009 ↗InjuryJul 18, 2019Unstable
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-3021-2020 · Aug 7, 2020 · Open, ClassifiedRSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
- Z-3022-2020 · Aug 7, 2020 · Open, ClassifiedRSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
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.
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