DJO SURGICAL 520-46-318Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, Offset Humeral Head, 46X18 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00190446176220), received between Jan 26, 2018 and May 5, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
6 other recalls cover devices cleared under the same FDA submission (K162024); 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 Problem4
- Appropriate Device Problem Term/Code Not Available4
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information5
- Failure of Implant1
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 21878798 ↗InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL - HOSPITALIZATION "INITIAL" OR PROLONGED.
Patient problems: Insufficient Information
MAUDE report 16143262 ↗InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - ROTATOR CUFF FAILED SO SURGEON CONVERTED PATIENT TO A REVERSE SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15898846 ↗InjurySep 7, 2021Detachment of Device or Device Component
COMPLAINT - THESE ITEMS WERE NOT CHARGED TO THE HOSPITAL, THE HEAD KEPT DISENGAGING FROM THE TRUNNION UPON IMPACTION. ANOTHER HEAD AND NECK WERE OPENED AND WORKED PERFECTLY.
Patient problems: Insufficient Information
MAUDE report 12432821 ↗InjuryApr 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO LOOSE GLENOID COMPONENT. REVISED TO REVERSE.
Patient problems: Insufficient Information
MAUDE report 11655085 ↗InjuryApr 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO HEAD EXCHANGE BECAUSE THE PATIENT FELL AND DISLOCATED HER SHOULDER.
Patient problems: Insufficient Information
MAUDE report 11627035 ↗InjuryApr 5, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
InjurySep 25, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9118415 ↗InjuryJan 26, 2018Insufficient Device Problem Information
REVISION SURGERY - THE SURGEON REMOVED THE ITEMS AND CHANGED TO A REVERSE.
Patient problems: No Code Available
MAUDE report 7222012 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162024. One submission often covers many models, so check the product and lot details in each record.
- Z-2331-2021 · Jun 28, 2021 · Open, ClassifiedAltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16
- Z-1258-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1256-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1260-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated
- Z-1259-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
- Z-1257-2018 · Jan 29, 2018 · CompletedAltivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as
Other PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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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