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Comprehensive® 110031414Recalls & reported problems

Zimmer, Inc. · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868231469), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 injury.

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 Problem1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST IMPLANTATION THE PATIENT IS EXPERIENCING ITCHING IN AND AROUND THE SHOULDER AND ALL OVER HIS BODY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 11457024 ↗

Other prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices

All prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented devices →

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