Sidus® Stem-Free Shoulder 01.04555.120Recalls & 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 00889024397170), received between Dec 20, 2018 and Mar 4, 2024 — classified as 1 death, 5 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
- Appropriate Device Problem Term/Code Not Available2
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Human-Device Interface Problem1
- Insufficient Device Problem Information1
Patient problems
- Pain4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Arthralgia1
- Inadequate Osseointegration1
- Loss of Range of Motion1
- No Information1
- Osteolysis1
- Subluxation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT PRIMARY ANATOMICAL TOTAL SHOULDER. SUBSEQUENTLY, APPROXIMATELY TWO YEARS POST IMPLANTATION THE PATIENT WAS CONVERTED TO A LEFT REVERSE TOTAL SHOULDER REPLACEMENT DUE TO SUBSCAPULARIS FAILURE AND SUBLUXATION OF THE HUMERAL HEAD; HUMERAL COMPONENT WAS FOUND GROSSLY LOOSE. GLENOID COMPONENT AND HUMERAL HEAD WERE EXPLANTED. DILIGENCE IS COMPLETE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Osteolysis; Pain; Subluxation
MAUDE report 18828319 ↗DeathMay 11, 2022Human-Device Interface Problem; Human-Device Interface Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN AND LACK OF MOTION. HEAD AND ANCHOR WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED YET.
Patient problems: Arthralgia; Loss of Range of Motion; Pain
MAUDE report 14352088 ↗InjuryDec 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
INVESTIGATION HAS BEEN COMPLETED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Inadequate Osseointegration
MAUDE report 11014977 ↗InjuryAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS NOW REPORTED THAT THERE IS A STUDY FOR THIS CASE: "SIDUS STEM-FREE SHOULDER STUDY" (CME2012-01E) IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO UNKNOWN REASON.
Patient problems: No Information
MAUDE report 8904898 ↗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, DIFFICULTY WITH ADLS.
Patient problems: Pain
MAUDE report 8183824 ↗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, DIFFICULTY WITH ADLS.
Patient problems: Pain
MAUDE report 8183812 ↗
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
- DJO SURGICAL 520-08-021Encore Medical, L.P. · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained20 reports
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page