DJO SURGICAL 520-42-116Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 42-16 · 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 00888912025027), received between Sep 28, 2015 and Aug 14, 2025 — classified as 14 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 Problem5
- Appropriate Device Problem Term/Code Not Available5
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Microbial Contamination of Device1
- Unstable1
Patient problems
- No Code Available3
- Insufficient Information2
- Unspecified Infection2
- Fall1
- Implant Pain1
- Injury1
- Joint Dislocation1
- Joint Disorder1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND IT CAUSED INSTABILITY.
Patient problems: Fall
MAUDE report 13231502 ↗InjuryJul 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PREVIOUS INFECTED SHOULDER WITH HEMI. CONVERTED HEMI TO TOTAL SHOULDER.
Patient problems: Unspecified Infection
MAUDE report 12213213 ↗InjuryMay 20, 2021Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - POST OPERATION INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 11858438 ↗InjuryJan 25, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - HEAD EXCHANGE FOR INSTABILITY AND/OR HINGMENT.
Patient problems: Insufficient Information
MAUDE report 11225205 ↗InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PUT GLENOID COMPONENT IN BECAUSE THE PATIENT PRESENTED PAIN.
Patient problems: Pain
MAUDE report 9208400 ↗InjuryAug 24, 2018Microbial Contamination of Device
SECOND REVISION SURGERY - DUE TO THE COMPONENTS BEING REMOVED IN AN ATTEMPT TO REVISE THE PATIENT TO A REVERSE TOTAL SHOULDER SINCE THE INFECTION WAS CLEANED UP. THE COMPONENTS WERE PLACE AS AN ANTIBIOTIC SPACER DURING A REVISION SURGERY.
Patient problems: Unspecified Infection
MAUDE report 7814352 ↗InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING A ROTATOR CUFF TEAR.
Patient problems: Injury; No Code Available
MAUDE report 7381134 ↗InjuryNov 30, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING ROTATOR CUFF ARTHROPATHY AND LOOSENING OF THE GLENOID COMPONENT. THE SURGEON CONVERTED THE TURON SHOULDER INTO A REVERSE SHOULDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7072353 ↗InjuryJan 16, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT RECEIVED AN ANATOMIC TOTAL SHOULDER ON (B)(6) 2015, HER ROTATOR CUFF HAS SINCE TORN. THE SURGEON WAS ABLE TO LEAVE THE ORIGINAL TURON STEM AND CONVERT HER TO A REVERSE SHOULDER.
Patient problems: No Code Available
MAUDE report 6254627 ↗InjurySep 29, 2016Unstable
REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE AND THE STEM HAVING SUBSIDED.
Patient problems: No Code Available
MAUDE report 5988841 ↗InjurySep 28, 2015Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING A NONFUNCTIONING ROTATOR CUFF. THE SURGEON EXCHANGED THE ORIGINAL NECK AND HEAD.
Patient problems: Joint Disorder
MAUDE report 5108757 ↗
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-0798-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Z-0801-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
- Z-0799-2011 · Nov 5, 2010 · TerminatedTuron Shoulder System Instrumentation, Turon Trial Humeral Neck, 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.
How reports and recalls are matched · Editorial policy · Report an error on this page