Comprehensive® Shoulder System 113630Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868267772), received between Aug 26, 2022 and Sep 18, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: Failure of Implant

  MAUDE report 20249573 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SEVEN (7) YEARS LATER, THE PATIENT IS WAS REVISED DUE TO LOOSENING OF IMPLANTS AND A INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC CEMENT SPACER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 15300032 ↗
• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SEVEN (7) YEARS LATER, THE PATIENT IS WAS REVISED DUE TO LOOSENING OF IMPLANTS AND A INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC CEMENT SPACER.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 15300029 ↗

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