Comprehensive® SRS 211216Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304522725), received between Sep 19, 2025 and Nov 26, 2025 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pain2
- Extraskeletal ossification1
- Tendinopathy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 23660792 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD A INITIAL LEFT REVERSE TOTAL SHOULDER. SUBSEQUENTLY, IT WAS REPORTED APPROXIMATELY 5 YEAR POST-IMPLANTATION THE PATIENT RECEIVED 3 SEPARATE CORTISONE INJECTIONS DUE TO PAIN AND SIGNS OF TENDONITIS. THE EVENT WAS REPORTED AS RESOLVED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Extraskeletal ossification; Pain; Tendinopathy
MAUDE report 23100073 ↗
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 · TerminatedZimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstructio
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED devices
- COMPREHENSIVE SHOULDER SYSTEM 113629Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall2 reports
- COMPREHENSIVE SHOULDER SYSTEM 113617Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- Comprehensive® Shoulder System 113607Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall1 report
- COPELAND SHOULDER SYSTEM 11-114647Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114643Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114641Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COPELAND SHOULDER SYSTEM 11-114644Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
- COMPRESS DEVICE 178787Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.