DJO SURGICAL 509-00-436Recalls & reported problems
Encore Medical, L.P. · RSP HUMERAL SOCKET INSERT, 36MM +4MM, STANDARD HXe-plus · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO RSP humeral socket insert has 121 adverse event reports, with no deaths and 121 injuries. Many reports describe infections needing revision surgery, along with shoulder dislocations and looseness or instability. 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
- 124
- Deaths reported
- 0
- Injuries reported
- 124
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00888912144582), received between Oct 12, 2016 and Sep 28, 2026 — classified as 124 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 reports).
1 other recall cover devices cleared under the same FDA submission (K100741); 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 Problem72
- Appropriate Device Problem Term/Code Not Available19
- Device Dislodged or Dislocated19
- Unstable18
- Fracture2
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection49
- Joint Dislocation23
- Joint Laxity21
- No Code Available9
- Failure of Implant7
- Insufficient Information7
- No Known Impact Or Consequence To Patient3
- Pain3
Recent adverse event reports
The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50926533 ↗InjurySep 11, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50744261 ↗InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50724620 ↗InjurySep 1, 2026Device Dislodged or Dislocated
Patient problems: Joint Dislocation
MAUDE report 50554109 ↗InjuryJul 10, 2026Unstable
InjuryJun 29, 2026Unstable
InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
REVISION DUE TO TIGHTNESS/ POSSIBLE NERVE PALSY.
Patient problems: Insufficient Information
MAUDE report 24837595 ↗InjuryApr 9, 2026Unstable
PATIENT FELT SHOULDER WAS TOO LOOSE AND NOT STABLE. STABLE.
Patient problems: Joint Laxity
MAUDE report 24837594 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 17, 2026Fracture
REVISION SURGERY - DUE TO PATIENT HAS A HUMERUS FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 24373566 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2025Unstable; Unstable
InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 23, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO CHRONIC ACROMION FRACTURE AND INSTABILITY.
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 23366094 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23059683 ↗InjurySep 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 22800993 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 23, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under K100741. One submission often covers many models, so check the product and lot details in each record.
- Z-1458-2026 · Jan 15, 2026 · Open, ClassifiedBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
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
- DELTA XTEND 130790024Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED122 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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