Sidus® Stem-Free Shoulder 01.04555.420Recalls & 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: 4
Deaths reported: 0
Injuries reported: 4
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024415928), received between Dec 7, 2018 and Mar 4, 2024 — classified as 4 injuries.

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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information2
Detachment of Device or Device Component1
Device Dislodged or Dislocated1

Patient problems

Pain2
Failure of Implant1
Loss of Range of Motion1
No Information1
Osteolysis1
Subluxation1

Recent adverse event reports

The 4 most recent of 4 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 18828316 ↗
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 ↗
InjuryOct 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
INVESTIGATION RESULT IS AVAILABLE NOW.
Patient problems: Loss of Range of Motion
MAUDE report 9171917 ↗
InjuryDec 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO REVISION TO REVERSE SHOULDER. DEVICE IS NOT BROKEN. A ROTATOR CUFF FAILURE OCCURRED AND THEREFORE A REVISION TO REVERSE SHOULDER WAS PERFORMED.
Patient problems: Failure of Implant
MAUDE report 8140874 ↗

Device details

UDI-DI	`00889024415928`
Brand	Sidus® Stem-Free Shoulder
Model	01.04555.420
Company	Zimmer GmbH
Product code	PKC · Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 9, 2022

Device type (GMDN): Total shoulder prosthesis

A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

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

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

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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