Comprehensive® Shoulder System 113664Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304462540), received between Oct 7, 2024 and Oct 24, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K060692, K193038); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT DISLOCATED ONE DAY AFTER THE PRIMARY SURGERY. UPON REVISING, IT WAS NOTED THAT THE PROXIMAL HUMERUS HAD FRACTURED, CAUSING THE UNCEMENTED STEM TO DESTABILISE MOVE DISTALLY, CREATING INSTABILITY IN THE JOINT CONSTRUCT. THE PATIENT PRIOR TO PRIMARY PROCEDURE HAD SIGNIFICANT BILATERAL BONE LOSS ON BOTH THE GLENOID AND PROXIMAL HUMERUS. CUSTOM GLENOID WAS REQUIRED, AND FRACTURE STEM USED. NO FURTHER INFORMATION IS KNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20521990 ↗
• MalfunctionOct 7, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON OPENING AND INSPECTING THE STEM PACKAGING THAT A DRY GREEN STAIN WAS DISCOVERED WHICH MAY HAVE COMPROMISED THE STERILITY OF THE DEVICE. THE SURGEON CHOSE A DIFFERENT IMPLANT FOR THE PROCEDURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384317 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060692, K193038. One submission often covers many models, so check the product and lot details in each record.

• Z-1403-2025 · Mar 3, 2025 · Open, Classified
  Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
• 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