DJO SURGICAL 520-46-024Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, NEUTRAL, 46-24 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912145169), received between Mar 23, 2016 and Jan 23, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K080402); 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 Problem4
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information1
- Material Disintegration1
- Unstable1
Patient problems
- Insufficient Information2
- No Code Available2
- Joint Dislocation1
- Joint Laxity1
- Loss of Range of Motion1
- No Information1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REMOVAL OF HEMI AND ADDITION OF GLENOID COMPONENTS TO COMPLETE REVERSE PROCEDURE, UNKNOWN REVISION.
Patient problems: Insufficient Information
MAUDE report 24173037 ↗InjuryDec 10, 2024Unstable; Unstable
REVISION SURGERY DUE TO PATIENT DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 20898983 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY -HEMIARTHROPLASTY CONVERTED TO A RSA.
Patient problems: Insufficient Information
MAUDE report 18472309 ↗InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISED THE HEMIARTHROPLASTY FOR PAIN AND LACK OF RANGE OF MOTION. SURGEON REMOVED THE LARGE TURON HEAD AND NECK ADAPTOR AND REPLACED IT WITH A SMALLER HEAD AND NEW ADAPTER.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 9905099 ↗InjuryAug 15, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THIS IS THE FINAL STAGE IN A PLANNED STAGED REVERSE.
Patient problems: No Information
MAUDE report 8897502 ↗InjuryFeb 4, 2019Insufficient Device Problem Information
REVISION SURGERY - THE PATIENT'S HEMI- ARTHROPLASTY IMPLANTS WERE REMOVED AND CONVERTED TO A REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 8302910 ↗InjuryMar 23, 2016Material Disintegration
REVISION SURGERY - DUE TO THE SUBSCAPULARIS REPAIR HAVING FAILED; AND CAUSING ROTATOR CUFF DETERIORATION. THE SURGEON WANTED TO CONVERT TO A REVERSE SHOULDER PROSTHESIS.
Patient problems: No Code Available
MAUDE report 5521785 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080402. One submission often covers many models, so check the product and lot details in each record.
- Z-0799-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
- Z-0798-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Z-0800-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
- Z-0801-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
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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