DJO SURGICAL 520-42-120Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 42-20 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912145138), received between May 12, 2017 and Oct 4, 2023 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 Problem3
- Device Operates Differently Than Expected1
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- Insufficient Information1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Insufficient Information
MAUDE report 16342844 ↗InjuryNov 10, 2020Unstable
SECOND REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10815850 ↗InjuryAug 16, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE TOTAL SHOULDER WAS CONVERTED TO A REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 6798216 ↗InjuryJul 28, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT'S SUB SCAP FAILING; THE SURGEON NEEDED TO CONVERT THE TURON TO A REVERSE TOTAL SHOULDER
Patient problems: No Code Available
MAUDE report 6750765 ↗InjuryMay 12, 2017Loose or Intermittent Connection
REVISION SURGERY - THE PATIENT WAS EXPERIENCING PAIN DUE TO A LOOSE GLENOID. THE SURGEON REMOVED HEAD AND IMPLANTED A THINNER HEAD.
Patient problems: Failure of Implant; Pain
MAUDE report 6564829 ↗
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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