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Sidus® Stem-Free Shoulder 01.04555.110Recalls & 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
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024397163), received between Nov 20, 2019 and Nov 7, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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

  • Insufficient Device Problem Information3
  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Degraded1
  • Device Dislodged or Dislocated1
  • Patient Device Interaction Problem1

Patient problems

  • Pain5
  • Metal Related Pathology2
  • Insufficient Information1
  • Loss of Range of Motion1
  • Unspecified Tissue Injury1

Recent adverse event reports

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

  • InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF SHOULDER IMPLANT DUE TO PAIN AND ROTATOR CUFF TEAR. DURING THE SURGERY THERE WERE SIGNS OF METALLOSIS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Patient problems: Metal Related Pathology; Pain

    MAUDE report 15742416 ↗
  • InjurySep 13, 2022Degraded; Patient Device Interaction Problem; Degraded; 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 MISFORMED. DUE DILIGENCE IS IN PROGRESS.

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

    MAUDE report 15409620 ↗
  • InjurySep 10, 2020Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information

    PATIENT WAS IMPLANTED ON THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO PERSISTENT PAIN AND FUNCTIONAL SHOULDER DEFICIT.

    Patient problems: Insufficient Information; Pain

    MAUDE report 10513612 ↗
  • InjuryAug 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT WAS IN PHYSICAL THERAPY AND FELT A POP WITH A CORRESPONDING LOSS OF MOTION. THE X-RAYS REVEALED DISSOCIATION. A REVISION SURGERY IS PLANNED.

    Patient problems: Loss of Range of Motion

    MAUDE report 10441411 ↗
  • InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Patient problems: Pain

    MAUDE report 9353089 ↗
  • InjuryNov 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Patient problems: Pain

    MAUDE report 9346474 ↗

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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