DJO SURGICAL 508-65-001Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5mm WEDGE · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00190446822851), received between Feb 18, 2025 and Sep 28, 2026 — classified as 12 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unstable” (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 Problem7
- Unstable5
- Device Dislodged or Dislocated2
- Patient Device Interaction Problem2
- Detachment of Device or Device Component1
- Mechanical Problem1
Patient problems
- Joint Laxity7
- Failure of Implant5
- Bone Fracture(s)2
- Joint Dislocation2
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50926079 ↗InjurySep 17, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50812632 ↗InjuryAug 31, 2026Unstable; Device Dislodged or Dislocated
Revision Surgery - Due to Dislocation and Instability.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 50533646 ↗InjuryMay 22, 2026Device Dislodged or Dislocated; Patient Device Interaction Problem
REVISION SURGERY DUE TO DISASSOCIATION / IMPLANT BREAKAGE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 25257011 ↗InjuryApr 7, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PERIPHERAL SCREW BREAKING/ LOOSE BASEPLATE.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 24808595 ↗MalfunctionDec 4, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
INSTRUMENT FAILURE - DURING PERIPHERAL SCREW PLACEMENT, 1 SCREW HOLE WOULD NOT LOCK IN ANY SCREW HEAD. MULTIPLE SCREWS WERE TRIED IN THAT HOLE AND NONE WOULD ENGAGE. THE BASEPLATE WAS INSPECTED PRIOR TO IMPLANTING AND THERE WAS NO APPARENT DAMAGE TO THE HOLE THREADS. THE HOLE WAS ULTIMATELY LEFT EMPTY. NO RISK REPORTED. BROKEN/FRAGMENTED PIECES LEFT PIECES LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 23723571 ↗InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO BASEPLATE FAILURE.
Patient problems: Failure of Implant
MAUDE report 22538516 ↗InjuryJun 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY, LOSS OF BASEPLATE FIXATION.
Patient problems: Joint Laxity
MAUDE report 22216167 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FAILED IMPLANT.
Patient problems: Failure of Implant
MAUDE report 22128610 ↗InjuryJun 2, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO BONE FRACTURE AND INSTABILITY.
Patient problems: Bone Fracture(s); Joint Laxity
MAUDE report 22128594 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE BASEPLATE/CENTRAL SCREW BROKE.
Patient problems: Failure of Implant
MAUDE report 21406651 ↗
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-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-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-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-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-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.
- 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-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.
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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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