DJO SURGICAL 530-14-048Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 14X48mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446334927), received between Nov 7, 2021 and Mar 20, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 Problem4
- Loosening of Implant Not Related to Bone-Ingrowth2
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- Bone Fracture(s)3
- Fall1
- Insufficient Information1
- Joint Dislocation1
- Joint Laxity1
- Limb Fracture1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 3, 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 21511123 ↗InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 20488366 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2022Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - POST OPERATIVE PATIENT BEING TO FRACTURE, SURGEON WENT IN WITH A LONGER STEM.
Patient problems: Insufficient Information
MAUDE report 13231867 ↗InjuryNov 7, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - HUMERAL STEM WAS LOOSENED. SHOULDER WAS DISLOCATED DUE TO FALL.
Patient problems: Fall; Joint Dislocation
MAUDE report 12762235 ↗
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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