Skip to content

Comprehensive® 110031411Recalls & reported problems

Zimmer, Inc. · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868231438), received between Feb 6, 2023 and Feb 6, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (1 report).

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

  • Positioning Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionFeb 6, 2023Positioning Failure; Positioning Failure

    IT WAS REPORTED A PATIENT UNDERWENT A REVERSE TOTAL SHOULDER. DURING THE PROCEDURE THE IMPLANT WAS NOTED TO BE LOOSE, AND SURGERY WAS COMPLETED WITH DIFFERENT SIZE IMPLANT THEN THE ONE TRIALED. NO SERIOUS INJURY OR IMPACT TO THE PATIENT WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16303600 ↗

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.