DJO SURGICAL 530-10-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 10X108mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical reverse shoulder replacement humeral stem used in shoulder arthroplasty. The 38 reports mostly describe the stem loosening within the bone, infection around the implant, and instability of the joint, with several patients needing revision surgery to remove or replace it; a few also mention a fracture. No deaths were reported, and all 38 reports describe injuries. There are no recalls naming 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00888912168366), received between May 11, 2017 and May 4, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 reports).
3 other recalls cover devices cleared under the same FDA submission (K141990); 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 Problem15
- Appropriate Device Problem Term/Code Not Available9
- Loose or Intermittent Connection5
- Loosening of Implant Not Related to Bone-Ingrowth5
- Unstable4
- Device Dislodged or Dislocated2
- Fracture2
- Improper or Incorrect Procedure or Method1
Patient problems
- Joint Laxity11
- No Code Available8
- Unspecified Infection6
- Insufficient Information4
- Failure of Implant3
- Bacterial Infection1
- Bone Fracture(s)1
- Fracture, Arm1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE REVERSE SHOULDER THAT WAS DONE YEARS AGO WAS INFECTED SO DOTOR REMOVED ALL IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 25075538 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IMPLANT LOOSENING / POTENTIAL INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 24879885 ↗InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFECTION IN HUMOROUS, LOOSE STEM.
Patient problems: Septic loosening; Unspecified Infection
MAUDE report 23763838 ↗InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO HUMERAL FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 20679406 ↗InjurySep 5, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS GETTING SOME DRAINAGE FROM THE INCISION FROM THE ORG SURGERY.
Patient problems: Failure of Implant
MAUDE report 18026731 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 10, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - BAD PATIENT BONE RESULTED IN CEMENTED STEM LOOSENING. USED A REVISION 10X175 REVISION STEM CEMENTED STEM TO REPLACE.
Patient problems: Insufficient Information
MAUDE report 15202829 ↗InjuryApr 12, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - PATIENT HAS HAD A HISTORY OF VARIOUS INFECTION RESULTING IN MULTIPLE IRRIGATION & DRAINAGE WITH LINER CHANGES. SURGEON DISCOVERED PRIMARY STEM WAS LOOSE AND OPTED TO REMOVE AND REPLACE, IN ADDITION TO REPLACING HEAD AND LINER.
Patient problems: Bacterial Infection
MAUDE report 14085985 ↗InjuryDec 21, 2021Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Insufficient Information
MAUDE report 13052667 ↗InjuryDec 16, 2021Loose or Intermittent Connection
REVISION SURGERY - DUE TO LOOSE HUMERAL STEM.
Patient problems: Insufficient Information
MAUDE report 13018325 ↗InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available
InjurySep 9, 2021Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - STEM HEAD LOOSENED, NEEDED TO CEMENT IN NEW STEM.
Patient problems: Insufficient Information
MAUDE report 12448924 ↗InjuryMay 12, 2021Packaging Problem
PRIMARY SURGERY - DURING INSPECTION OF IMPLANT BEFORE OPENING ONTO THE STERILE FIELD A HAIR WAS DISCOVERED INSIDE THE PACKAGING OF THE IMPLANT. THE HAIR WAS IN THE INNER MOST LAYER (IMPLANT LAYER) OF THE PACKAGING. SURGEON WAS ABLE TO GRAB ANOTHER IMPLANT OF THE SHELF SO THERE WAS NO DISRUPTION IN THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11812407 ↗InjuryOct 6, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - LOOSE SHOULDER DUE TO COMPONENTS.
Patient problems: No Code Available
MAUDE report 10634778 ↗InjurySep 23, 2020Loose or Intermittent Connection
REVISION SURGERY - HUMERUS FRACTURE CAUSED LOOSE STEM.
Patient problems: Fracture, Arm
MAUDE report 10574473 ↗InjuryAug 28, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - LOOSE STEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10466883 ↗InjuryJun 23, 2020Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - TOOK OUT THE OLD STEM THAT SURGEON MADE INTO A SPACER.
Patient problems: No Code Available
MAUDE report 10185023 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141990. One submission often covers many models, so check the product and lot details in each record.
- Z-1241-2018 · Jan 30, 2018 · TerminatedAltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral soc
- Z-0626-2016 · Dec 8, 2015 · TerminatedAltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for us
- Z-0131-2016 · Sep 15, 2015 · TerminatedAltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is
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.
How reports and recalls are matched · Editorial policy · Report an error on this page