DJO SURGICAL 530-14-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, STANDARD SHELL, SZ 14X108mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912168489), received between Oct 26, 2016 and Sep 17, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 Problem3
- Appropriate Device Problem Term/Code Not Available3
- Loose or Intermittent Connection3
- Unstable3
- Device Dislodged or Dislocated1
- Device Slipped1
- Failure To Adhere Or Bond1
- Malposition of Device1
Patient problems
- No Code Available4
- Insufficient Information3
- Joint Laxity3
- No Known Impact Or Consequence To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50812266 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 3, 2025Unstable; Unstable
InjuryNov 18, 2025Adverse 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
InjuryJun 6, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT WAS DISLOCATING DUE TO INSTABILITY. SO SURGEON SWITCHED OUT THE STEM AND BUILT UP THE POLY LINER.
Patient problems: Insufficient Information
MAUDE report 14605636 ↗InjuryJan 31, 2022Output Problem
REVISION SURGERY: PATIENT HAD A RE-DO OF A TENDON TRANSFER AND NEEDED AN ALLOGRAFT. THE SURGEON EXPLANTED THE STEM AND POLY, AND REPLACED THE SCREW IN THE CENTER OF THE GLENOSPHERE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13403656 ↗InjuryJun 28, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REVISION OF PREVIOUS HYBRID CONSTRUCT.
Patient problems: Insufficient Information
MAUDE report 12080858 ↗InjuryJan 7, 2021Loose or Intermittent Connection
REVISION SURGERY - STEM CAME LOOSE. PATIENT WAS NOT SURE HOW IT HAPPENED.
Patient problems: Failure of Implant
MAUDE report 11133664 ↗InjuryJul 31, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - UNKNOWN REASONS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10351071 ↗InjuryFeb 23, 2018Positioning Problem
SECOND REVISION SURGERY - THE PATIENT WAS CONVERTED FROM TURON TOTAL SHOULDER TO ALTIVATE REVERSE, AND INITIALLY DID VERY WELL BUT BECAME VERY TIGHT AND STIFF FOLLOWING SURGERY. THE DECISION WAS MADE TO REVISE TO A MORE MEDIALIZED GLENOSPHERE AND A LOOSER CONSTRUCT, ACHIEVED BY REPOSITIONING THE HUMERAL STEM TO TAKE TENSION OFF OF DELTOID.
Patient problems: No Code Available
MAUDE report 7293317 ↗InjuryJan 19, 2018Device Slipped
REVISION SURGERY - THE STEM WAS PRESS FIT, BUT IT BECAME LOOSE. THE SURGEON REMOVED THE STEM, 8MM SPACER AND INSERT. THE SURGEON REPLACED THE INSERT AND CEMENTED IN A NEW STEM.
Patient problems: No Information
MAUDE report 7205834 ↗InjuryDec 20, 2017Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT HAVING DISLOCATED AT HIS 4 WEEK FOLLOW UP APPOINTMENT. THE SURGEON REVISED HIM TO MAKE THE SHOULDER STABLE. NONE OF THE IMPLANTS HAD ANY PROBLEMS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7135407 ↗InjuryAug 11, 2017Malposition of Device
REVISION SURGERY - DUE TO THE STEM ROTATING IMMEDIATELY FOLLOWING OPERATION DUE TO AN ACCIDENT.
Patient problems: No Code Available
MAUDE report 6790426 ↗InjuryFeb 6, 2017Loose or Intermittent Connection; Unstable
REVISION SURGERY - DURING THE PATIENT'S INITIAL SURGERY, THE SURGEON BELIEVED TO HAVE AN ADEQUATE PRESS-FIT WITH HIS STEM, BUT NOTICED INSTABILITY AT THE PATIENT'S TWO WEEK FOLLOW UP. THE STEM DID NOT LOOK LOOSE ON THE X-RAY AND THE SURGEON PLANNED ON EXCHANGING THE HEAD AND POLY LINER DURING THE REVISION. DURING THE REVISION SURGERY, THE STEM WAS FOUND TO BE GROSSLY LOOSE AND NEVER ACHIEVED A PRESS-FIT IN THE ORIGINAL SURGERY. HE CEMENTED IN A STEM AND IMPLANTED A NEW SPACER, LINER AND HEAD AND THE SHOULDER WAS STABLE.
Patient problems: No Code Available
MAUDE report 6304001 ↗InjuryOct 26, 2016Failure To Adhere Or Bond; Loose or Intermittent Connection
REVISION SURGERY - DUE TO NON FIXATION, LOOSE STEM. THE SURGEON REMOVED ALL OF THE COMPONENTS AND PUT IN A ANTIBIOTIC SPACER.
Patient problems: No Code Available
MAUDE report 6058050 ↗
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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