DJO SURGICAL 520-54-118Recalls & reported problems
Encore Medical, L.P. · HEAD, HUMERAL, OFFSET, 54-18 · 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 00888912025089), received between Sep 15, 2015 and Aug 23, 2025 — classified as 5 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 Problem1
- Appropriate Device Problem Term/Code Not Available1
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Material Rupture1
Patient problems
- Insufficient Information2
- No Code Available1
- No Information1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: REVISED A HEMI INTO AN ANATOMIC SHOULDER, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22881226 ↗InjuryMay 4, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THERE WAS WEARING FROM THE HEAD.
Patient problems: Insufficient Information
MAUDE report 14273532 ↗InjuryApr 11, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING PAIN. THE PATIENT HAD A HEMI IN PLACE. A GLENOID COMPONENT WAS PLACED.
Patient problems: Pain
MAUDE report 7423324 ↗InjuryJun 23, 2017Device Operates Differently Than Expected
REVISION SURGERY - THE SURGEON WANTED TO REMOVE THE TOTAL SHOULDER AND CONVERT TO A REVERSE TOTAL SHOULDER BECAUSE OF A FAILING ROTATOR CUFF.
Patient problems: No Information
MAUDE report 6664921 ↗InjurySep 15, 2015Material Rupture
REVISION SURGERY - DUE TO THE PATIENT SUFFERING FROM A SUB SCAPULA RUPTURE.
Patient problems: No Code Available
MAUDE report 5078007 ↗
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-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
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