COMPREHENSIVE SHOULDER SYSTEM 113609Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304554108), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Naturally Worn” (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.

• InjuryMar 25, 2021Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY PERFORMED APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT REPORTED TO HER SURGEON THAT SHE HAD BEEN DOING FINE UNTIL SHE REACHED DOWN TO GRAB SOMETHING AND FELT A PAIN IN HER LEFT SHOULDER. FOLLOW UP RADIOLOGY CONFIRMED FRACTURE OF THE CENTRAL SCREW WITH SUBSEQUENT LOOSENING AND OSTEOLYSIS FROM DEBRIS GENERATION. THE PATIENT REPORTS SHE HAS SINCE HAD PAIN, DIFFICULTY WITH ADLS, AND LIMITED RANGE OF MOTION. NO REVISION HAS BEEN REPORTED OR PLANNED TO DATE. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cyst(s); Failure of Implant; Loss of Range of Motion; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Subluxation

  MAUDE report 11570067 ↗

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-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-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-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