COMPREHENSIVE SHOULDER SYSTEM 113634Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304449732), received between Jun 10, 2020 and Jun 10, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 10, 2020Fracture; Fracture

  IT WAS REPORTED PATIENT SUFFERED PAIN DUE TO DISASSOCIATED PROSTHESIS APPROXIMATELY ONE MONTH POST-IMPLANTATION. DUE TO SHORT NOTICE, REPLACEMENT IMPLANTS AND INSTRUMENTS WERE NOT AVAILABLE. THE SURGEON REATTACHED THE GLENOSPHERE AND HUMERAL BEARING TO BASEPLATE, USED 2 JUGGERKNOTS TO HELP STABILIZE THE SHOULDER. TWO CERCLAGE WIRES WERE ATTACHED TO SITE. THE COMPREHENSIVE STEM HAD FRACTURED. PATIENT WILL BE OBSERVED TO SEE HOW HE DOES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10137813 ↗

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