DJO SURGICAL 533-08-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 8X108MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a DJO Surgical Altivate Reverse shoulder implant, a reverse-configuration humeral stem used in shoulder replacement. The 58 reports mostly describe the stem working loose in the bone, along with joint instability, dislocation and fractures around the implant, and several patients needing revision surgery. All58 reports involve injuries and none report a death. 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
- 59
- Deaths reported
- 0
- Injuries reported
- 59
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00190446259121), received between May 9, 2019 and Sep 8, 2026 — classified as 59 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (7 reports).
3 other recalls cover devices cleared under the same FDA submission (K172351); 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 Problem35
- Appropriate Device Problem Term/Code Not Available11
- Loose or Intermittent Connection7
- Fracture5
- Loosening of Implant Not Related to Bone-Ingrowth5
- Unstable4
- Device Dislodged or Dislocated3
Patient problems
- Joint Laxity28
- Bone Fracture(s)8
- Insufficient Information7
- Unspecified Infection5
- No Known Impact Or Consequence To Patient4
- Joint Dislocation3
- Implant Pain2
- Limb Fracture2
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2026Fracture
Patient problems: Bone Fracture(s)
MAUDE report 50678682 ↗InjuryJul 8, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO THE PATIENT WAS UNSTABLE AND DISLOCATING.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 25755514 ↗InjuryJun 25, 2026Fracture
REVISION SURGERY - DUE TO DISTAL HUMERAL FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 25628145 ↗InjuryJun 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 12, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 18, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryDec 9, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED FRACTURE OF RIGHT HUMERUS BELOW STEM. SURGEON OPTED TO REVISE WITH PRESS FIT FRACTURE STEM AND UPSIZE GLENOSPHERRE. 62 YR OLD FEMALE.
Patient problems: Bone Fracture(s)
MAUDE report 23763847 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO NON-UNION PROXIMAL HUMERUS.
Patient problems: Failure of Implant
MAUDE report 20626861 ↗InjuryNov 5, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FAILED REVISION REVERSE. A CEMENT SPACER WAS PUT IN.
Patient problems: Insufficient Information
MAUDE report 19978330 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE, INSTABILITY AND PAIN.
Patient problems: Implant Pain; Joint Laxity; Limb Fracture
MAUDE report 19823577 ↗InjuryJun 8, 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 K172351. One submission often covers many models, so check the product and lot details in each record.
- Z-0281-2024 · Sep 25, 2023 · Open, ClassifiedRSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
- Z-2607-2023 · Aug 4, 2023 · Open, ClassifiedDJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108
- Z-0117-2021 · Aug 31, 2020 · TerminatedAltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of
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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