DJO SURGICAL 520-46-124Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 46-24 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912145190), received between Feb 15, 2016 and Apr 1, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Appropriate Device Problem Term/Code Not Available2
- Adverse Event Without Identified Device or Use Problem1
- Inadequacy of Device Shape and/or Size1
- Torn Material1
Patient problems
- No Code Available2
- Joint Dislocation1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED SIX YEARS POST OPERATION FOLLOWING A REVISION SPACER. SURGEON DETERMINED THAT INFECTION WAS STILL PRESENT AND OPTED TO REVISE AGAIN. ALL PREVIOUS COMPONENTS WERE REMOVED AND NEW SPACER COMPONENTS WERE IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 13060333 ↗InjuryAug 7, 2019Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - THE PATIENT WAS IN A LOT OF PAIN AND THE SURGEON WAS CONVERTING TO A TOURNIER REVERSE. NO DJO COMPONENTS WERE IMPLANTED.
Patient problems: Pain
MAUDE report 8871779 ↗InjuryOct 27, 2017Torn Material
REVISION SURGERY - DUE TO TORN ROTATOR CUFF; THE SURGEON TOOK OUT THE TURON COMPONENTS AND REPLACED WITH REVERSE SHOULDER PROSTHESIS COMPONENTS.
Patient problems: No Code Available
MAUDE report 6985360 ↗InjuryFeb 15, 2016Inadequacy of Device Shape and/or Size
REVISION SURGERY - DUE TO THE PATIENT REQUIRING A THINNER HEAD OPTION.
Patient problems: No Code Available
MAUDE report 5437251 ↗
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-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-0799-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Humeral Neck, 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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