DJO SURGICAL 530-12-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 12X108mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical Altivate Reverse humeral stem is the metal shoulder implant component used in shoulder replacement surgery. The 27 reports mostly describe the stem loosening in the bone or the shoulder joint coming apart, along with infections and a break in the bone near the implant, leading patients to need repeat surgery. No deaths were reported, but all 27 reports involved injuries. Reports were more frequent in the past year, rising from 1 to 6, 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888912168427), received between May 25, 2017 and Sep 21, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 Problem14
- Device Dislodged or Dislocated6
- Appropriate Device Problem Term/Code Not Available4
- Fracture4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Unstable2
- Loose or Intermittent Connection1
Patient problems
- Joint Laxity8
- Joint Dislocation5
- Bone Fracture(s)4
- Unspecified Infection4
- Failure of Implant2
- Insufficient Information2
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Fracture
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 50849238 ↗InjuryMay 4, 2026Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT WAS DISLOCATED. REVISION SURGERY WAS SCHEDULED. WHILE ATTEMPTING TO REMOVE POLY, THE STEM WAS DEEMED LOOSE AND THUS REMOVED.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25074798 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT PRESENTED TO DOCTOR'S OFFICE WITH RIGHT SHOULDER PAIN. X-RAY SHOWED LOOSE STEM. THE DOCTOR WENT IN AND CONFIRMED A LOOSE STEM WE REPLACED THE STEM AND THE POLY LINER.
Patient problems: Joint Laxity
MAUDE report 24990879 ↗InjuryDec 15, 2025Unstable; Unstable
THE PATIENT HAD HUMERAL LOOSENING AND NEEDED TO HAVE A LONGER CEMENTED STEM.
Patient problems: Aseptic loosening; Joint Laxity
MAUDE report 23810208 ↗InjuryDec 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
PATIENT CAME IN WITH LOOSE STEM AND AN EXPECTED INFECTION. SURGEON DECIDED TO REMOVE ALL COMPONENTS AND PLACE A SPACER. MALE 61YRS.
Patient problems: Joint Laxity; Septic loosening; Unspecified Infection
MAUDE report 23810165 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 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 21770080 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; 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
REVISION SURGERY - DUE TO THE SURGEON REMOVED THE STEM AND DID A BONE GRAF.
Patient problems: Insufficient Information
MAUDE report 19455665 ↗InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND PAIN.
Patient problems: Implant Pain; Joint Dislocation
MAUDE report 18813564 ↗InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT'S JOINT WAS UNSTABLE.
Patient problems: Joint Laxity
MAUDE report 18237178 ↗InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION. STEM WAS LOOSE. UPSIZED COMPONENTS.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 16015379 ↗InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERI-PROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 15498087 ↗InjuryJul 1, 2022Fracture; Device Dislodged or Dislocated
REVISION SURGERY - DISLOCATION DUE TO FRACTURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14888567 ↗InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT PRESENTED WITH INFECTION. IMPLANTS REMOVED DURING CLEAN OUT.
Patient problems: Unspecified Infection
MAUDE report 14888500 ↗InjurySep 20, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS UNSTABLE REQUIRING A NEW STEM, INSERT AND GLENOID HEAD. NO PRODUCT FAILURE.
Patient problems: Insufficient Information
MAUDE report 12500461 ↗InjuryJul 13, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PROXIMAL HUMERUS FRACTURE IN WHICH STEM BROKE IN HALF.
Patient problems: Bone Fracture(s)
MAUDE report 12159677 ↗InjuryAug 3, 2020Loose or Intermittent Connection
REVISION SURGERY - LOOSENING OF HUMERAL STEM REVISED TO A LARGER STEM.
Patient problems: Failure of Implant; No Code Available
MAUDE report 10355744 ↗InjuryMar 12, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT'S SHOULDER DISLOCATED. REMOVED AND EXCHANGED OUT THE STEM AND INSERT.
Patient problems: Joint Dislocation
MAUDE report 9825941 ↗InjuryJun 7, 2019Fracture
REVISION SURGERY - DUE TO A HUMERAL FRACTURE DISTAL TO THE HUMERAL STEM.
Patient problems: No Code Available
MAUDE report 8678981 ↗InjuryMay 10, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO THE PATIENT DISLOCATING.
Patient problems: No Information
MAUDE report 8599389 ↗InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT SUFFERING A FRACTURE IN HER HUMERUS AFTER HER PRIMARY SHOULDER SURGERY. IT WAS DECIDED BY THE SURGEON AND PATIENT THAT A REVISION SURGERY WAS NEEDED TO TAKE OUT THE PRIMARY HUMERAL STEM AND PUT A LONGER STEM IN THAT WOULD REDUCE THE FRACTURE. A SUCCESSFUL REVISION OF THE HUMERAL STEM COMPONENTS AND GLENOID HEAD WAS PERFORMED.
Patient problems: Fracture, Arm
MAUDE report 8493362 ↗
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.
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