DJO SURGICAL 533-12-108Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE, HUMERAL STEM, SMALL SHELL, SZ 12X108MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is the DJO Surgical Altivate Reverse shoulder implant's small humeral stem. The 27 reports describe a loose or unstable shoulder joint that dislocates or shifts, sometimes with infection or a break in the bone near the implant, and in most cases the patient ended up having revision surgery. No deaths were reported, but 27 injuries were. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00190446259183), received between May 1, 2019 and Sep 24, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Unstable” (6 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 Problem16
- Unstable6
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated2
- Loose or Intermittent Connection2
- Loosening of Implant Not Related to Bone-Ingrowth2
- Fracture1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Joint Laxity13
- Joint Dislocation5
- Unspecified Infection5
- Bone Fracture(s)3
- Insufficient Information3
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50876513 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 29, 2026Unstable
InjuryMar 24, 2026Fracture; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO DISLOCATION AND FRACTURE.
Patient problems: Bone Fracture(s); Joint Dislocation
MAUDE report 24678297 ↗InjuryJan 16, 2026Unstable; Patient Device Interaction Problem
REVISION SURGERY - DUE TO LOOSENING AND INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 24090833 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
InjuryNov 21, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 23493122 ↗InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 5, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21317576 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN, FRACTURE AND INFECTION.
Patient problems: Bone Fracture(s); Implant Pain; Limb Fracture; Unspecified Infection
MAUDE report 21074526 ↗InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND LOOSENING.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21050490 ↗InjuryJul 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 19590500 ↗InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 19337941 ↗InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND DISLOCATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 17066765 ↗InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 1, 2022Insufficient Device Problem Information
REVISION SURGERY : GREATER TUBEROSITY FRACTURE. DECIDED TO DOWNSIZE AND CEMENT.
Patient problems: Insufficient Information
MAUDE report 13418168 ↗InjuryJul 15, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE REASON IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 12177073 ↗InjuryNov 5, 2020Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO CHALLENGING PATIENT DISLOCATED. NEEDED BIGGER SIZE IMPLANTS.
Patient problems: Joint Dislocation
MAUDE report 10793233 ↗InjurySep 3, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10488578 ↗InjuryAug 26, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD DRAINAGE AND LOOSE STEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10454225 ↗
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 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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