Comprehensive® Shoulder System 113034Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304212213), received between Nov 30, 2022 and Nov 29, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K040610, K060716, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 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 ANATOMIC SHOULDER REPLACEMENT ONE (1) YEAR AND NINE MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE PATIENT'S ROTATOR CUFF FAILING. THE IMPLANT WAS EXPLANTED AND A GLENOSPHERE WAS IMPLANTED ALONG WITH A MIN BASEPLATE, SCREWS, AND MINI HUMERAL TRAY AND BEARING.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18226911 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO DISASSOCIATION OF THE GLENOID AND METAL POST. DURING THE REVISION, FOUND THE STEM WITH SIGNIFICANT METALLOSIS TYPE OF DEBRIS AROUND IT, RESORPTION NOTED AROUND THE NECK OF THE HUMERUS AND THE CALCAR, SYNOVITIS RESULTING IN A COMPLETE SYNOVECTOMY, A PIECE OF THE POLYETHYLENE BASEPLATE THAT FRACTURED OFF AND WAS LEFT ATTACHED TO THE INGROWTH POST, WEAR TO THE GLENOID, AND SIGNIFICANT GLENOID DAMAGE WITH POSTERIOR EROSION AND A B2 TYPE OF CONFIGURATION. ALL COMPONENTS WERE REMOVED WITHOUT COMPLICATION AND COMPETITOR PRODUCT WAS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 15887829 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040610, K060716, 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