COMPREHENSIVE SHOULDER SYSTEM 113651Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304461130), received between Jan 6, 2026 and Jan 6, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K060692); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Difficult to Insert; Difficult to Remove; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A COMPREHENSIVE SHOULDER ARTHROPLASTY, A SIZE 11 HUMERAL STEM COULD NOT BE ADVANCED AND BECAME STUCK INTRA-OPERATIVELY. DURING THE PROCEDURE, THE HUMERUS WAS REAMED FOR A SIZE 11 STANDARD STEM AND RASPED WITH A SIZE 11 HUMERAL RASP. THE IMPLANTED SIZE 11 PROSTHESIS COULD NOT ADVANCE BY APPROXIMATELY 1 CM AND COULD NEITHER BE FULLY INSERTED NOR REMOVED. AFTER APPROXIMATELY 2 HOURS OF UNSUCCESSFUL ATTEMPTS TO ADJUST OR REMOVE THE STEM, THE PROXIMAL HUMERUS WAS SPLIT TO FACILITATE REMOVAL, AND A SIZE 10 STEM WAS SUBSEQUENTLY IMPLANTED SUCCESSFULLY. THE PATIENT WAS IMPLANTED WITH A SIZE 10 HUMERAL STEM SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23976057 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060692. One submission often covers many models, so check the product and lot details in each record.

• Z-1543-2020 · Feb 17, 2020 · Terminated
  Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component o
• Z-0591-2019 · Oct 10, 2018 · Terminated
  Comprehensive Mini Stem, Item No. 113631:
• Z-0980-2018 · Dec 8, 2017 · Terminated
  Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
• Z-0979-2018 · Dec 8, 2017 · Terminated
  Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
• Z-0299-2018 · Jun 5, 2017 · Terminated
  COMP PRIMARY STEM 8MM MINI, model # 113628
• Z-1755-2015 · Apr 16, 2015 · Terminated
  Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, hum