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Sidus® Stem-Free Shoulder 01.04555.440Recalls & reported problems

Zimmer GmbH · Class 2 · Implant

All models of Sidus Stem-Free Shoulder (9)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
1
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024415935), received between Dec 20, 2018 and Jun 1, 2023 — classified as 1 death, 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

Most reported problems

Device problems

  • Device Dislodged or Dislocated2
  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Insufficient Device Problem Information1
  • Noise, Audible1
  • Patient Device Interaction Problem1
  • Positioning Problem1

Patient problems

  • Metal Related Pathology2
  • Pain2
  • Angina1
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Arthralgia1
  • Cardiac Arrest1
  • Heart Failure/Congestive Heart Failure1
  • Inadequate Osseointegration1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • DeathJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: Angina; Cardiac Arrest; Heart Failure/Congestive Heart Failure; Ischemic Heart Disease; Pulmonary Edema; Pulmonary Embolism

    MAUDE report 17036913 ↗
  • InjurySep 13, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN ABOUT 9 YEARS POST INITIAL HEMI ARTHROPLASTY. ROTATOR CUFF TEAR WAS CONFIRMED ON CT SCAN AND REVISION SURGERY TOOK PLACE. DURING REMOVAL OF THE IMPLANTS, IT WAS NOTED THERE WAS METALLOSIS AND ANCHOR HAD WORN AND DISFORMED. DUE DILIGENCE IS IN PROGRESS. .

    Patient problems: Metal Related Pathology; Pain; Unspecified Tissue Injury

    MAUDE report 15409634 ↗
  • InjuryDec 15, 2020Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

    INVESTIGATION HAS BEEN COMPLETED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration

    MAUDE report 11015089 ↗
  • InjuryAug 19, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Patient problems: Arthralgia; Joint Dislocation; Metal Related Pathology; Toxicity

    MAUDE report 10425225 ↗
  • InjuryAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Patient problems: No Information

    MAUDE report 8904895 ↗
  • InjuryDec 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND IS BEING MONITORED DUE TO PAIN, DECREASED RANGE OF MOTION.

    Patient problems: Pain

    MAUDE report 8183821 ↗

Other Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices

All Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained devices →

Sources and updates

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