Comprehensive® SRS 211256Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304507814), received between Aug 14, 2023 and May 22, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111746, 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.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INITIAL LEFT TOTAL HUMERAL ARTHROPLASTY WAS PERFORMED. THE PATIENT SUBSEQUENTLY DEVELOPED A WOUND-HEALING COMPLICATION. APPROXIMATELY TWO AND A HALF MONTHS AFTER THE INDEX PROCEDURE, DEBRIDEMENT OF SOFT TISSUE AND ANTIBIOTIC THERAPY WERE PERFORMED. ALL IMPLANTS REMAINED IMPLANTED. AT ONE-YEAR FOLLOW-UP, THE PATIENT REPORTED BEING SATISFIED. DUE DILIGENCE IS COMPLETE FOR THIS COMPLAINT; IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE, AND TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25258099 ↗
• InjuryMar 19, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION DUE TO DETACHMENT OF THE MODULAR HEAD. THE PATIENT WAS EXPERIENCING PAIN PRIOR TO THE REVISION. THE HEAD AND BODY WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 24639386 ↗
• InjuryAug 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IMPLANT DISASSOCIATION DUE TO MISASSEMBLY AT IMPLANTATION APPROXIMATELY ONE MONTH POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 17544318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111746, 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