DJO SURGICAL 508-36-107Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE GLENOSPHERE 36mm/+4mm W/RETAINING SCREW · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Altivate reverse shoulder implant is a metal-and-polymer shoulder replacement component. The 24 reports mainly describe the implant or joint dislocating, sometimes with infection, pain, or revision surgery; they include 24 injuries and no deaths. No recalls name this device. Reports rose from 7 in the previous 12 months to 16 in the most recent 12 months.
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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00190446759904), received between Oct 9, 2024 and Jul 29, 2026 — classified as 25 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).
8 other recalls cover devices cleared under the same FDA submission (K233481); 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 Problem16
- Device Dislodged or Dislocated5
- Unstable2
- Detachment of Device or Device Component1
- Fracture1
- Patient Device Interaction Problem1
Patient problems
- Joint Dislocation12
- Unspecified Infection5
- Joint Laxity3
- Implant Pain2
- Pain2
- Bone Fracture(s)1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Device Dislodged or Dislocated
InjuryJul 6, 2026Device Dislodged or Dislocated
InjuryJun 18, 2026Device Dislodged or Dislocated
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 19, 2026Patient Device Interaction Problem
InjuryApr 16, 2026Device Dislodged or Dislocated
InjuryApr 6, 2026Device Dislodged or Dislocated
InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2026Unstable
InjuryMar 2, 2026Fracture
REVISION SURGERY - DUE TO GLENOID FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 24492394 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD INFECTION AND THE SURGEON REPLACED THE LINER AND GLENOSPHERE.
Patient problems: Unspecified Infection
MAUDE report 23824458 ↗InjuryDec 10, 2025Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component
GLENOSPHERE DETACHED FROM THE BASEPLATE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 23774412 ↗InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD PAIN FOLLOWING SURGERY THOUGHT MAYBE IT WAS TOO TIGHT OR HAD SUPERIOR SCREW IN THE NERVE.
Patient problems: Pain
MAUDE report 23774411 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT COMPLAINT OF SHOULDER PAIN.
Patient problems: Implant Pain
MAUDE report 23460073 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under K233481. One submission often covers many models, so check the product and lot details in each record.
- Z-2547-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
- Z-2549-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended
- Z-2546-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile
- Z-2548-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
- Z-2011-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.
- Z-2009-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.
- Z-2010-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.
- Z-2008-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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