COMPREHENSIVE SHOULDER SYSTEM 113607Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304554085), received between Jan 24, 2024 and Jan 24, 2024 — classified as 1 injury.

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 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FRACTURE REVERSE SHOULDER ABOUT 3 YEARS AGO. UNFORTUNATELY, THE PRIMARY HAD FAILED AS THE PATIENT SUFFERED A PERI-PROSTHETIC FRACTURE BELOW THE DISTAL TIP OF THE IN-SITU STEM, WHILE USING THEIR ARM TO PUSH OFF OF A CHAIR. DURING THE REVISION THE EXISTING STEM WAS REMOVED (WHICH TOOK A LARGE CHUNK OF PROXIMAL HUMERAL BONE WITH IT). THE SURGEON THEN REAMED DOWN THE HUMERAL CANAL TO REPLACE THE STEM WITH AN SRS HUMERAL COMPONENT. DURING REAMING HE FOUND THAT THE REAMER SKIVED OFF AN EXISTING CEMENT RESTRICTOR FORM THE PRIMARY PROCEDURE AND PERFORATED THE HUMERAL CANAL. HE THEN HAD TO DRILL IN TO THE CEMENT RESTRICTOR TO BE ABLE TO REMOVE IT BEFORE PROCEEDING WITH HUMERAL REAMING. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE HUMERAL PREPARATION BEFORE TRIALING THE NEW HUMERAL COMPONENT ON THE EXISTING IN SITU GLENOSPHERE. THE SURGEON BEGAN WITH THE SMALLEST SRS PROXIMAL BODY BEFORE BUILDING UP TO THE 68MM BODY. HE ALSO TRIALED A NUMBER OF HUMERAL TRAY AND POLY CONSTRUCTS (FROM SMALLEST TO LARGEST) BEFORE SETTLING ON THE +5MM THICKNESS TRAY AND +3MM THICKNESS POLY. THIS WAS THEN IMPLANTED BEFORE CLOSING UP.

  Patient problems: Bone Fracture(s)

  MAUDE report 18574762 ↗

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