Comprehensive® Shoulder System 113627Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868267741), received between Oct 23, 2023 and Oct 7, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

1. Mar 3, 2025Open, Classified

   Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

   Z-1403-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

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 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 20383295 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY ONE (1) YEAR AND FOUR (4) MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS EXPERIENCING FLUID COLLECTION IN THE SHOULDER AND UNDERWENT A WASHOUT APPROXIMATELY TWO (2) MONTHS AGO. DURING THE WASHOUT, THE SURGEON NOTED METALLOSIS, WHICH WAS LATER CONFIRMED WITH A CULTURE TEST. THERE WAS ALSO NOTE OF BASEPLATE FAILURE. THE PATIENT LATER UNDERWENT A REVISION APPROXIMATELY THREE (3) WEEKS AGO TO REMOVE THE IMPLANTS. MEDICAL IMAGES WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL AND IDENTIFIED DISASSOCIATION OF THE BASEPLATE, IMPLANT FRACTURE, AND OSTEOPENIC BONE QUALITY.

  Patient problems: Metal Related Pathology; Osteopenia/ Osteoporosis; Synovitis

  MAUDE report 17985474 ↗

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-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