DJO SURGICAL 520-50-218Recalls & reported problems
Encore Medical, L.P. · AltiVate Anatomic, Neutral Humeral Head, 50X18 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00190446176138), received between May 31, 2019 and Sep 28, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 Problem13
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated2
- Patient Device Interaction Problem2
Patient problems
- Unspecified Infection5
- Joint Dislocation4
- Discomfort2
- Implant Pain2
- Insufficient Information2
- Pain2
- Failure of Implant1
- Loss of Range of Motion1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Patient Device Interaction Problem
Patient problems: Pain
MAUDE report 50926525 ↗InjurySep 8, 2026Patient Device Interaction Problem
Patient problems: Discomfort
MAUDE report 50678687 ↗InjuryNov 20, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PAIN/DISCOMFORT.
Patient problems: Implant Pain
MAUDE report 22032628 ↗InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO REVISED FROM HEMIARTHROPLASTY TO REVERSE.
Patient problems: Insufficient Information
MAUDE report 21554674 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO POST-OP INFECTION.
Patient problems: Unspecified Infection
MAUDE report 20909255 ↗InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS HAVING PAIN AFTER HAVING A REAM N RUN DONE TWO YEARS PRIOR. DOCTOR DECIDED TO DO A FULL ANATOMIC SHOULDER.
Patient problems: Implant Pain
MAUDE report 19640106 ↗InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 16746698 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT INFECTED/ WASHOUT CASE.
Patient problems: Unspecified Infection
MAUDE report 14493360 ↗InjuryApr 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: SURGEON CONVERTED FROM A HEMI TO REVERSE SHOULDER PROSTHESIS BUT THE SURGEON USED ANOTHER COMPANY GLENOID COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 14044052 ↗InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY : DUE TO A POOR RANGE OF MOTION. A SMALLER HEAD WAS PUT ON THAN FROM THE PREVIOUS SURGERY.
Patient problems: Loss of Range of Motion
MAUDE report 13995098 ↗InjuryFeb 8, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION, NEEDED TO WASH IT OUT AND REPLACE HEMI ADAPTER AND HUMERAL HEAD.
Patient problems: Unspecified Infection
MAUDE report 13479966 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD PAIN AND SURGEON WAS CONCERNED SHE WAS INFECTED. RESECTED SOME SOFT TISSUE AND REPLACED THE HEAD AND NECK.
Patient problems: Pain
MAUDE report 11732011 ↗InjuryMay 31, 2019Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION PER SIZING. THE SURGEON REVISED TO A TOTAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8660146 ↗
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-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
- 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-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-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-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
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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