Comprehensive® SRS 211230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304507791), received between May 24, 2022 and Jul 25, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111746, K173411, K223631); 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.

• InjuryJul 25, 2023Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO HUMERAL LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17388146 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain; Peripheral Nervous Injury

  MAUDE report 16629977 ↗
• InjuryMay 24, 2022Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Migration; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COMPREHENSIVE SRS REVISION DUE TO UNKNOWN REASONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 14488840 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111746, K173411, K223631. One submission often covers many models, so check the product and lot details in each record.

• Z-1173-2018 · Feb 28, 2018 · Terminated
  Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstructio