DJO SURGICAL 530-08-048Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X48mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00190446334897), received between Mar 8, 2021 and Jun 8, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 Problem3
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Implant Pain2
- Insufficient Information2
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Detachment of Device or Device Component
HUMERAL STEM HAD DISASSOCIATED FROM HUMERUS.
Patient problems: Failure of Implant
MAUDE report 25429203 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
POST OP PAIN - REVISED STEM WITH A STYKER FRACTURE STEM AND CHANGED GLENOSPHERE. 63 YR OLD MALE.
Patient problems: Implant Pain
MAUDE report 24643026 ↗InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SURGEON HAD TO REMOVE MORE BONE TO REMOVE THE TAP OUT. RESULTING IN ARG WITH THE REVISION BASE PLATE. THEN TIGHTENING THE ARG.
Patient problems: Insufficient Information
MAUDE report 21428862 ↗InjuryOct 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 6, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT CONTINUED TO DISLOCATE. SHORT STEM WAS IN SLIGHT VALGUS. REVISED TO 8X108MM STEM WITH 8MM SPACER AND 32N LINER.
Patient problems: Joint Dislocation
MAUDE report 12125471 ↗InjuryMar 8, 2021Fracture
REVISION SURGERY - PERI-PROSTHETIC FRACTURE. MID-SHAFT HUMERUS.
Patient problems: Insufficient Information
MAUDE report 11435666 ↗
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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