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Comprehensive® Shoulder System 113634Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868267819), received between Sep 9, 2022 and Sep 7, 2023 — classified as 2 injuries.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Discomfort1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Discomfort

    MAUDE report 17700773 ↗
  • InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY APPROXIMATELY FIVE MONTHS AGO. CURRENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO PAIN AND LOSS OF RANGE OF MOTION. HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Patient problems: Pain

    MAUDE report 15389774 ↗

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

Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices

All PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.