Comprehensive® Shoulder System 113044Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304212237), received between Apr 9, 2020 and Apr 6, 2022 — classified as 3 injuries.

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

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

• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION FOR AN UNKNOWN REASON ON AN UNKNOWN DAY.. ATTEMPTS HAVE BEEN MADE AND IT WAS REPORTED THAT THE CASE WAS CANCELLED. NO FURTHER INFORMATION IS AVAILABLE FORM THE EVENT AT THIS TIME.

  Patient problems: Insufficient Information; Muscle/Tendon Damage; Osteolysis

  MAUDE report 14025425 ↗
• InjuryMar 2, 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 4 MONTHS POSTIMPLANTATION DUE TO PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 13656343 ↗
• InjuryApr 9, 2020Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Loosening of Implant Not Related to Bone-Ingrowth

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

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

  MAUDE report 9943715 ↗

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