Comprehensive® Shoulder System 113022Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Comprehensive Shoulder System (68)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304212183), received between Mar 21, 2024 and Sep 8, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 other recall cover devices cleared under the same FDA submission (K040610, K060716, K193038); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Unintended Movement1
Patient problems
- Joint Dislocation2
- Loss of Range of Motion2
- Pain2
- Adhesion(s)1
- Connective Tissue Disease1
- Erosion1
- Joint Impingement1
- Muscle/Tendon Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY TWO (2) YEARS AND THREE (3) MONTHS POST-IMPLANTATION DUE TO RECURRENT DISLOCATION. THE PATIENT WAS CONVERTED FROM A COMPREHENSIVE HYBRID ANATOMIC SHOULDER TO A COMPREHENSIVE REVERSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 22998406 ↗InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT UNDERWENT A SHOULDER REVISION DUE TO SUBSCAPULARIS FAILURE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Muscle/Tendon Damage
MAUDE report 22564977 ↗InjuryNov 18, 2024Unintended Movement; Unintended Movement
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: Adhesion(s); Erosion; Joint Dislocation; Joint Impingement; Loss of Range of Motion; Osteopenia/ Osteoporosis; Pain; Subluxation
MAUDE report 20706165 ↗InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER ASSESSED THAT THE PAIN WAS DUE TO ROTATOR CUFF TEAR, THEREFORE, THIS IS A NOT REPORTABLE EVENT AS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.
Patient problems: Connective Tissue Disease; Loss of Range of Motion; Pain
MAUDE report 18953839 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040610, K060716, K193038. One submission often covers many models, so check the product and lot details in each record.
- Z-1403-2025 · Mar 3, 2025 · Open, ClassifiedComprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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