DJO SURGICAL 520-00-000Recalls & reported problems
Encore Medical, L.P. · NECK, HUMERAL, NEUTRAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical neutral humeral neck implant, the ball-and-socket piece used in shoulder replacement. The 30 reports describe the device not working as expected and the shoulder joint dislocating or the socket side wearing out and loosening, with several patients needing a second operation for infection, pain, fracture, or a reverse shoulder replacement. All 30 reports describe injuries, with no deaths. No recalls name this device, and no reports were filed in the past 12 months.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888912024884), received between Sep 29, 2015 and Jul 20, 2023 — classified as 30 injuries.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (8 reports).
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.
Most reported problems
Device problems
- Device Operates Differently Than Expected8
- Adverse Event Without Identified Device or Use Problem6
- Insufficient Device Problem Information4
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated2
- Naturally Worn2
- Patient-Device Incompatibility2
- Break1
Patient problems
- No Code Available12
- No Known Impact Or Consequence To Patient3
- Unspecified Infection3
- No Information2
- Pain2
- Excessive Tear Production1
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 9, 2023Naturally Worn; Naturally Worn
InjuryFeb 4, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SHOULDER DISLOCATED. SURGEON REMOVED THE NEUTRAL NECK AND INSERTED THE 7.5 ANGLED NECK TO FIND BETTER STABILITY.
Patient problems: Insufficient Information
MAUDE report 11278918 ↗InjuryJan 10, 2020Fracture
InjuryDec 31, 2019Loose or Intermittent Connection
REVISION SURGERY - GLENOID COMPONENT FAILED, THE HEAD WAS LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9535314 ↗InjuryDec 13, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT'S SUBSCAP FAILING AND REQUIRING A REVISION TO A REVERSE TO STABILIZE AND REGAIN NORMAL FUNCTION.
Patient problems: Failure of Implant
MAUDE report 8162676 ↗InjuryJul 27, 2018Naturally Worn
InjuryJul 13, 2018Device Dislodged or Dislocated
REVISION SURGERY - DUE TO A DISLOCATION. THE SURGEON CONVERTED FROM A TURON TO A REVERSE SHOULDER PROSTHESIS (RSP) FOR REPEATED DISLOCATION. THE SURGEON REMOVED ALL TURON IMPLANTS AND REPLACED WITH SHOULDER IMPLANTS.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 7687083 ↗InjuryMar 23, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7367440 ↗InjuryMar 6, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING A ROTATOR CUFF TEAR AND THEREFORE REQUIRED CONVERSION TO A REVERSE SHOULDER REPLACEMENT.
Patient problems: Injury
MAUDE report 7317502 ↗InjuryMar 5, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE SURGEON CONVERTING TO A REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 7314492 ↗InjuryFeb 19, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE SURGEON FINDING THAT THE PATIENT HAD A FAILED ROTATOR CUFF. HE ALSO SAID THAT THE PATIENT HAD RHEUMATOID ARTHRITIS.
Patient problems: Rheumatoid Arthritis
MAUDE report 7281198 ↗InjuryFeb 6, 2018Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT'S ROTATOR CUFF FAILING APPROXIMATELY 4 YEARS POST-OPERATIVE AND REQUIRING A REVERSE TOTAL SHOULDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7244431 ↗InjuryDec 21, 2017Device Operates Differently Than Expected
SECOND REVISION SURGERY - DUE TO A SUB SCAPULA FAILURE.
Patient problems: No Code Available
MAUDE report 7137908 ↗InjuryDec 4, 2017Patient-Device Incompatibility
REVISION SURGERY - DUE TO AN INFECTION. THE SURGEON REMOVED THE IMPLANTS AS PART OF 2 STAGE REVISION FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7080285 ↗InjuryNov 14, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A SUBSCAPULARIS FAILURE.
Patient problems: No Code Available
MAUDE report 7029179 ↗InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE REVISION CASE WAS BY ANOTHER COMPANY. ANOTHER SURGEON PLANNED ON REMOVING ALL OF THE IMPLANTS BUT THE STEM WAS TOO WELL FIXED IN HUMERUS, SO JUST REMOVED AND REPLACED THE NECK AND HEAD.
Patient problems: No Information
MAUDE report 6888094 ↗InjuryAug 16, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO THE PATIENT HAVING SUBSCAP FAILURE AND THE SURGEON DECIDING THE PATIENT NEEDED TO HAVE A CONVERSION TO A REVERSE SHOULDER.
Patient problems: No Information
MAUDE report 6797299 ↗InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO THE PATIENT HAVING PAIN; THE SURGEON DID A REVISION OF A HEMI TO A TOTAL SHOULDER.
Patient problems: Pain
MAUDE report 6734807 ↗InjuryJun 22, 2017Device Operates Differently Than Expected
REVISION SURGERY - DUE TO A BAD ROTATOR CUFF.
Patient problems: No Code Available
MAUDE report 6660175 ↗InjuryJun 9, 2017Break
REVISION SURGERY - DUE TO ROTATOR CUFF DAMAGE, THE PATIENT WAS REVISED TO A REVERSE SHOULDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6629269 ↗InjuryMay 31, 2017Patient-Device Incompatibility
REVISION SURGERY - DUE TO A TORN SUBSCAP MUSCLE.
Patient problems: Excessive Tear Production
MAUDE report 6603012 ↗InjuryMar 13, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE HEMI NEEDING TO BE CONVERTED TO TOTAL.
Patient problems: No Code Available
MAUDE report 6400820 ↗InjuryMar 7, 2017Improper or Incorrect Procedure or Method; Device Operates Differently Than Expected
REVISION SURGERY -THE PATIENT WAS NOT COMPLAINT AND DID NOT WEAR A SLING AFTER THE PRIMARY SURGERY; THE PATIENT HAD A FAILED SUB-SCAPULAR.
Patient problems: No Code Available
MAUDE report 6386087 ↗
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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