Sidus Stem-Free ShoulderRecalls & reported problems across all models
Zimmer GmbH · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 3
- Injuries reported
- 27
- Recalls
- 1
We found 9 models of Sidus Stem-Free Shoulder by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2018 and Mar 4, 2024 — classified as 3 deaths, 27 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Sidus Stem-Free Shoulder recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 21, 2019Terminated
Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Z-2762-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Sidus Stem-Free Shoulder problems
Device problems
- Insufficient Device Problem Information7
- Device Dislodged or Dislocated5
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available4
- Loosening of Implant Not Related to Bone-Ingrowth4
- Detachment of Device or Device Component2
- Patient Device Interaction Problem2
- Degraded1
Patient problems
- Pain18
- Failure of Implant5
- Metal Related Pathology5
- Joint Dislocation3
- Loss of Range of Motion3
- No Information3
- Osteolysis3
- Angina2
Sidus Stem-Free Shoulder models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sidus® Stem-Free Shoulder 01.04555.500Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 recall1 report
- Sidus® Stem-Free Shoulder 01.04555.110Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained6 reports
- Sidus® Stem-Free Shoulder 01.04555.120Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 death6 reports
- Sidus® Stem-Free Shoulder 01.04555.440Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 death6 reports
- Sidus® Stem-Free Shoulder 01.04555.130Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 death4 reports
- Sidus® Stem-Free Shoulder 01.04555.420Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained4 reports
- Sidus® Stem-Free Shoulder 01.04555.400Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 report
- Sidus® Stem-Free Shoulder 01.04555.460Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 report
- Sidus® Stem-Free Shoulder 01.04555.520Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained1 report
Recent Sidus Stem-Free Shoulder adverse event reports
The 15 most recent reports across all models, 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 ↗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 18828316 ↗InjuryAug 2, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT PATIENT WITH TOTAL SHOULDER PROSTHESIS HAS BEEN REVISED FOUR (4) YEARS AFTER INITIAL SURGERY DUE TO PAIN, LINER FRACTURE AND DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Joint Dislocation; Pain
MAUDE report 17441502 ↗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 ↗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; Pain; Pulmonary Edema; Pulmonary Embolism
MAUDE report 17036912 ↗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 ↗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 15742415 ↗InjuryOct 20, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPLACEMENT SURGERY AND APPROXIMATELY 4 YEARS LATER A REVISION TO A SPACER WAS PERFORMED DUE TO INFECTION AND LOOSENING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Failure of Implant; Osteolysis; Unspecified Infection
MAUDE report 15637076 ↗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 ↗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 ↗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; 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 ↗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 ↗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 ↗InjurySep 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO PERSISTENT PAIN AND FUNCTIONAL SHOULDER DEFICIT.
Patient problems: No Information; Pain
MAUDE report 10513605 ↗
Other Zimmer GmbH products
- Affixus Natural Nail55 models · 612 reports
- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Wagner SL Revision33 models · 66 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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