DJO SURGICAL 520-08-021Recalls & reported problems
Encore Medical, L.P. · ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00190446648314), received between Nov 7, 2021 and Apr 23, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
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 Problem14
- Appropriate Device Problem Term/Code Not Available4
- Fracture2
- Device Dislodged or Dislocated1
- Material Split, Cut or Torn1
- Patient Device Interaction Problem1
- Unstable1
Patient problems
- Unspecified Infection5
- Failure of Implant4
- Implant Pain3
- Insufficient Information2
- Joint Dislocation2
- Pain2
- Arthralgia1
- Bone Fracture(s)1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - IMPLANTS DID NOT FAIL. PATIENT WAS JUST IN PAIN AND NEEDED TO BE CONVERTED TO REVERSE, DUE TO FAILED CUFF.
Patient problems: Pain
MAUDE report 24974726 ↗InjuryMar 21, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO PATIENT WITH FAILED TOTAL SHOULDER.
Patient problems: Failure of Implant
MAUDE report 24657086 ↗InjuryMar 13, 2026Fracture
REVISION SURGERY - DUE TO PERIPROSTHETIC FRACTURE.
Patient problems: Bone Fracture(s)
MAUDE report 24592335 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FAILED HEMI SHOULDER.
Patient problems: Failure of Implant
MAUDE report 22583419 ↗InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 10, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 20898984 ↗InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DISLOCATION AND INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 18882648 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD A REAM AND RUN PROCEDURE DONE ORIGINALLY. AFTER PAIN, SURGEON DECIDED TO REVISE TO A REVERSE.
Patient problems: Pain
MAUDE report 15996956 ↗InjuryJun 21, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DISLOCATION AND SUBSCAPULAR FAILURE.
Patient problems: Failure of Implant
MAUDE report 14758093 ↗InjuryJan 18, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO FAILED ROTATOR CUFF.
Patient problems: Failure of Implant
MAUDE report 13284442 ↗InjuryJan 4, 2022Fracture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FRACTURED.
Patient problems: Insufficient Information
MAUDE report 13161166 ↗InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available; Material Split, Cut or Torn
REVISION SURGERY : PATIENT HAD A TORN ROTATOR CUFF AND THE SURGEON REMOVED ALL IMPLANT AND DID A REVERSE TOTAL SHOULDER ARTHROPLASTY.
Patient problems: Insufficient Information
MAUDE report 12762099 ↗
Other Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices
- Tornier Perform DWM003ATornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- Sidus® Stem-Free Shoulder 01.04555.500Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- INHANCE 5200-00-036Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained17 reports
- Easytech Anatomical Shoulder System 314-0038Fx Solutions · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained14 reports
- Tornier Simpliciti® Shoulder System 7122872Tornier, Inc. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained9 reports
- Sidus® Stem-Free Shoulder 01.04555.110Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
- GLOBAL ICON 1140-10-054Depuy (Ireland) · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
- Sidus® Stem-Free Shoulder 01.04555.440Zimmer GmbH · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 death6 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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