DJO SURGICAL 530-12-048Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 12X48mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00190446334910), received between Jan 7, 2022 and Mar 20, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Fracture” (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 Problem9
- Appropriate Device Problem Term/Code Not Available3
- Fracture1
- Loose or Intermittent Connection1
Patient problems
- Bone Fracture(s)5
- Insufficient Information4
- Joint Laxity3
- Fall2
- Limb Fracture1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2026Fracture
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE
Patient problems: Bone Fracture(s)
MAUDE report 24656431 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SUBLUXATION/REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Insufficient Information
MAUDE report 16315183 ↗InjuryApr 1, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO LOOSENING OF HUMERAL STEM.
Patient problems: Insufficient Information
MAUDE report 13979821 ↗InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT FELL AND HAD A PERI PROSTHETIC FRACTURE. SURGEON REMOVED THE STEM AND IMPLANTED A LONGER REVISION STEM THAT PASSED THE FRACTURE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 13590874 ↗InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY : THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE. SURGEON REMOVED THE STEM AND IMPLANTED A LONGER REVISION STEM THAT PASSED THE FRACTURE.
Patient problems: Bone Fracture(s); Fall
MAUDE report 13577306 ↗InjuryJan 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD A REVERSE SHOULDER. STEM SPUN OUT HAD TO REMOVE THE SHORT STEM AND REIMPLANT STANDARD 10X108 CEMENTED STEM. SURGEON BELIEVES THAT PATIENT DID TOO MUCH SINCE THEY HAD SURGERY, RIGHT AFTER SURGERY.
Patient problems: Insufficient Information
MAUDE report 13198913 ↗InjuryJan 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD PAIN AND POSSIBLE INFECTION. REVISION WENT AS PLANNED WITH NO ISSUES.
Patient problems: Pain; Unspecified Infection
MAUDE report 13198901 ↗
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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