DJO SURGICAL 509-01-044Recalls & reported problems
Encore Medical, L.P. · RSP SEMICONSTRAINED HUMERAL SOCKET INSERT, 44MM, HXe-plus · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912144643), received between Jul 30, 2019 and Jun 8, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated2
- Unstable2
Patient problems
- Unspecified Infection10
- Joint Dislocation4
- Fall1
- Joint Laxity1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Unstable
InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 5, 2026Device Dislodged or Dislocated
InjurySep 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 23069684 ↗InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 7, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION. PATIENT FELL AND DISLOCATED.
Patient problems: Fall; Joint Dislocation; Unspecified Infection
MAUDE report 12130618 ↗InjuryJun 12, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10148245 ↗InjuryMar 20, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - PATIENT PRESENTED WITH INFECTION. ALL DJO PRODUCTS WERE REMOVED EXCEPT THE STEM. THE INFECTION LEFT A LARGE HOLE. SURGEON HAD TO BUILD A WEDGE & USE THE STRYKER GLENOSPHERE SYSTEM.
Patient problems: Unspecified Infection
MAUDE report 9860602 ↗InjuryJul 30, 2019Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY - PATIENT BECAME INFECTED SO SURGEON PERFORMED AN IRRIGATION & DRAINAGE WITH A POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 8843634 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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