DJO SURGICAL 533-10-048Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 10X48mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Altivate Reverse shoulder implant is a cemented stem used in shoulder replacement. Reports mostly describe fractures around the stem, dislocations, loosening and infections that mention further surgery to fix or replace the implant. FDA records show 23 reports mentioning 23 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00190446334972), received between Aug 3, 2020 and Sep 15, 2026 — classified as 24 injuries.
The most frequently reported specific device problem is “Fracture” (5 reports).
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 Problem14
- Fracture5
- Appropriate Device Problem Term/Code Not Available3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Unstable2
Patient problems
- Bone Fracture(s)8
- Joint Laxity4
- Limb Fracture3
- Pain3
- Failure of Implant2
- Insufficient Information2
- Unspecified Infection2
- Fall1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Fracture
Patient problems: Bone Fracture(s)
MAUDE report 50781684 ↗InjuryMay 14, 2026Fracture
REVISION SURGERY DUE TO THE PATIENT HAD A FRACTURE BELOW THE STEM.
Patient problems: Limb Fracture
MAUDE report 25167186 ↗InjuryFeb 18, 2026Fracture
InjuryNov 10, 2025Unstable; Unstable
IT WAS REPORTED THAT PATIENT REQUIRED REVISION SURGERY DUE TO DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 23519015 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; 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 PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 22024727 ↗InjuryDec 13, 2024Unstable; Unstable
InjurySep 10, 2024Adverse 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 20186467 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - STEM SUBSIDED A SMALL AMOUNT REVISED WITH A CEMENTED LONGER STEM.
Patient problems: Failure of Implant
MAUDE report 18204845 ↗InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL ON LEFT SHOULDER AND FRACTURED HUMERUS JUST UNDER DISTAL TIP OF IMPLANT.
Patient problems: Bone Fracture(s); Fall
MAUDE report 15634062 ↗InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY THE STEM WAS POTENTIALLY LOOSE AND THE PATIENT WAS IN PAIN.
Patient problems: Joint Laxity; Pain
MAUDE report 15575765 ↗InjuryAug 16, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - THE SURGEON NOTICED THE HUMERAL STEM WAS LOOSE AND NEEDED TO BE REVISED. HE WENT BACK IN AND SWAPPED THE GLENOID, POLY, AND STEM. SURGEON REVISED TO A SMALL SHELL 108 STEM WITH CEMENT. THE SURGEON IS HAPPY WITH THE RESULTS.
Patient problems: Failure of Implant
MAUDE report 15235815 ↗InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem
InjuryOct 15, 2021Appropriate Device Problem Term/Code Not Available
InjuryJun 2, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PERIPROSTHETIC FRACTURE OF STEM.
Patient problems: Insufficient Information
MAUDE report 11919122 ↗InjurySep 1, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT'S STEM WAS LOOSE, WHICH WAS CAUSING PAIN. REMOVED AND EXCHANGED THE STEM, LINER AND HEAD.
Patient problems: Pain
MAUDE report 10476878 ↗InjuryAug 3, 2020Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PROXIMAL HUMERAL FRACTURE. NEEDED TO CONVERT TO LARGER REVERSE STEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10355740 ↗
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.
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