DJO SURGICAL 530-08-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 8X108mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Altivate Reverse shoulder prosthesis humeral stem used in shoulder replacement surgery. The 35 reports mostly describe pain and joint instability after surgery, along with bone fractures, infections, and implants loosening or shifting, often leading to revision surgery; all 35 report injuries and no deaths. 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
- 36
- Deaths reported
- 0
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00888912168304), received between Nov 16, 2017 and Sep 9, 2026 — classified as 36 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Appropriate Device Problem Term/Code Not Available7
- Loose or Intermittent Connection6
- Fracture4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Device Dislodged or Dislocated2
- Unstable2
- Failure To Adhere Or Bond1
Patient problems
- Joint Laxity7
- Pain7
- Bone Fracture(s)6
- Insufficient Information4
- Unspecified Infection4
- Failure of Implant3
- Joint Dislocation2
- No Code Available2
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Fracture
Patient problems: Bone Fracture(s)
MAUDE report 50702454 ↗InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT WAS EXPERIENCING PAIN POST-OP. SURGEON SUSPECTED DUE TO FRACTURED TUBEROSITY OR LOOSE IMPLANTS. BOTH SEEMED TO BE THE CASE AND SURGEON REPLACED HUMERAL COMPONENTS AND CEMENTED THEM. SURGEON CERCLAGED THE TUBEROSITY AS WELL.
Patient problems: Joint Laxity; Pain
MAUDE report 24902437 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT FELL CAUSING DISCOMFORT AS WELL AS AN INFECTION MALE
Patient problems: Fall; Unspecified Infection
MAUDE report 23858011 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2025Unstable; Unstable
IT WAS REPORTED THAT PATIENT REQUIRED REVISION SURGERY TO TREAT INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 23519017 ↗InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINT - DUE TO THE POLY WAS EXTREMELY DIFFICULT TO IMPACT INTO THE STEM. TOOK HIM MORE THAN 10 IMPACTS TO FULLY SEAT IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20605300 ↗InjuryJul 22, 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 19802274 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT IMPINGEMENT AND LOOSE STEM.
Patient problems: Joint Laxity
MAUDE report 19465197 ↗InjuryMay 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY - DUE TO REVISION OF A REVISION, PLASTIC BETWEEN HEAD & ADAPTOR, IMPLANTS REMOVED AND NOTHING WAS IMPLANTED
Patient problems: Insufficient Information
MAUDE report 19274426 ↗InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SECOND STAGE REV, PUT IN A HEMI WITH ANTIBIOTIC CEMENT UNTIL THE PAT FRACTURES ARE HEALED AND THEN A NEW REVERSE CONSTRUCT WILL FIX THE PROBLEM.
Patient problems: Insufficient Information
MAUDE report 18378929 ↗InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - PAIN/LOOSENING.
Patient problems: Arthralgia; Joint Laxity
MAUDE report 18088699 ↗InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2023Adverse 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 STEM LOOSENING. EXACTECH HUMERAL RECONSTRUCTION PROSTHESIS USED ON HUMERAL SIDE.
Patient problems: Joint Laxity
MAUDE report 15498096 ↗InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available
InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available
InjuryJan 25, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
InjurySep 22, 2021Material Erosion; Loose or Intermittent Connection
REVISION SURGERY - PATIENT'S STEM WAS LOOSE. OSTEOLYSIS WAS PRESENT AND CEMENT WAS ERODED. NO INFECTION WAS FOUND. BASEPLATE/GLENOSPHERE WAS LEFT IN PATIENT. STEM/POLY/SPACER WAS REPLACED.
Patient problems: Failure of Implant
MAUDE report 12514934 ↗InjuryAug 11, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION.
Patient problems: Insufficient Information
MAUDE report 12308018 ↗InjuryJun 15, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - STEM SEEMED TO BE LOOSE ON FOLLOW UP. POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12005664 ↗InjuryApr 27, 2021Fracture
SECOND REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Failure of Implant
MAUDE report 11732022 ↗InjuryMar 24, 2021Fracture
REVISION SURGERY - SURGEON HAD A PATIENT WHO NEEDED A REVISION SURGERY DUE TO A FRACTURE. TOOK OUT 108 ALTIVATE REVERSE STEM AND PUT IN A SHORT STEM REVERSE. ALSO CHANGED LINER AND PUT IN A SPACER (8MM). PUT IN SEMI +4 LINER (40MM).
Patient problems: Failure of Implant
MAUDE report 11562363 ↗InjuryJan 25, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - HUMERAL LOOSENING OCCURRED AT SOME POINT AFTER STEM WAS IMPLANTED IN PATIENT. PATIENT EXPERIENCED PAIN WHEN MOVING HIS ARM.
Patient problems: Pain
MAUDE report 11225186 ↗
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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