DJO SURGICAL 520-50-018Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, NEUTRAL, 50-18 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912145206), received between Sep 23, 2016 and Jun 11, 2026 — classified as 14 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem6
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Loose or Intermittent Connection1
- Torn Material1
- Use of Device Problem1
Patient problems
- No Code Available5
- Joint Laxity3
- Failure of Implant2
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Device Dislodged or Dislocated
InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - TWO-STAGE ANTIBIOTIC REVISION, COMPLETED SECOND STAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18213154 ↗InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 31, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION IN THE RIGHT SHOULDER. REMOVED ALL ITEMS. REPLACED WITH OUR STEM, SOCKET INSERT, AND MONOBLOCK SPACER WITH SCREW. USED A DIFFERENT VENDOR FOR THE GLENOID.
Patient problems: Unspecified Infection
MAUDE report 11101816 ↗InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REMOVED TURON HEAD AND NECK. SWITCHED OUT WITH NEW NECK AND A NEW HEAD.
Patient problems: No Code Available
MAUDE report 10523290 ↗InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem
SECOND REVISION SURGERY - COMPONENTS THAT WERE USED AS AN ANTIBIOTIC SPACER WERE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9124830 ↗InjuryMay 14, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT BEING IN PAIN. NO TORN ROTATOR CUFF.
Patient problems: Pain
MAUDE report 8609924 ↗InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT TEARING HIS SUBSCAP AGAIN. THE SURGEON CONVERTED TO A REVERSE.
Patient problems: No Code Available
MAUDE report 7107990 ↗InjuryOct 12, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING HAD THE CONTRALATERAL (RIGHT) SIDE DONE ON (B)(6) 2017 AND SUBSEQUENTLY HAVING AN ISSUE WITH ORIGINAL (LEFT) SIDE, POSSIBLY DURING REHABILITATION. THE GLENOID COMPONENT ASEPTICALLY LOOSENED AND WAS EASILY REMOVED, THEN SUBSEQUENTLY CONVERTED TO A REVERSE USING CONVERSION MODULE (INITIAL STEM LEFT IN).
Patient problems: Failure of Implant; No Code Available
MAUDE report 6943934 ↗InjuryJun 9, 2017Appropriate Device Problem Term/Code Not Available
Patient problems: Failure of Implant
MAUDE report 6630076 ↗InjuryMay 8, 2017Use of Device Problem; Torn Material
REVISION SURGERY: DUE TO THE PATIENT TEARING HIS ROTATOR CUFF.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6552841 ↗InjuryJan 26, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE SURGEON CONVERTING FROM A HEMI TO A TOTAL SHOULDER.
Patient problems: No Code Available
MAUDE report 6279134 ↗InjurySep 23, 2016Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A FAILED HEMI SHOULDER; THE SURGEON CONVERTED TO A REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 5975166 ↗
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-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
- Z-0798-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Humeral Head Trials, 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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