Comprehensive® Shoulder System 113057Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304460775), received between Oct 16, 2023 and May 18, 2026 — classified as 3 injuries.

1 other recall cover devices cleared under the same FDA submission (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT SHOULDER HEMIARTHROPLASTY DUE TO HUMERAL NECK FRACTURE. THE PATIENT IS REQUESTING PRODUCT IDENTIFICATION TO SCHEDULE REVISION DUE TO PAIN AND LIMITED RANGE OF MOTION. PATIENT STATES ADDITIONAL RADIOLOGY REPORTS PROVIDE FINDINGS OF A COMPLETE TEAR OF THE TENDON AND SUSPICION OF LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Muscle/Tendon Damage; Pain

  MAUDE report 25203781 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO BONE FRACTURE. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Bone Fracture(s); Erosion

  MAUDE report 18830985 ↗
• InjuryOct 16, 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 LEFT SHOULDER ARTHROPLASTY APPROXIMATELY TWO YEARS AGO. THE PATIENT UNDERWENT A TWO-STAGE REVISION SURGERY, THE FIRST STAGE A YEAR AND A HALF AFTER THE INITIAL SURGERY AND THE SECOND APPROXIMATELY FOUR MONTHS AGO DUE TO THE SCREWS FRACTURING. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR AN ADDITIONAL REVISION SURGERY DUE TO THE PATIENT BEING UNHAPPY WITH THE RESULTS OF HER PREVIOUS REVISION SURGERIES AND DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 17942163 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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