Comprehensive® Shoulder System 110035767Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868249334), received between Jan 10, 2023 and Nov 13, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
- Detachment of Device or Device Component2
- Fracture2
- Naturally Worn2
- Difficult to Insert1
Patient problems
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544116 ↗InjuryApr 20, 2023Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE DISASSOCIATION OF BASEPLATE AND POLY. FURTHER, THE SURGEON ALSO STATED THAT THE POST WAS SHEARED OFF. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Failure of Implant
MAUDE report 16776980 ↗InjuryJan 10, 2023Fracture; Detachment of Device or Device Component; Naturally Worn; Fracture; Detachment of Device or Device Component; Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISASSOCIATION OF BASEPLATE AND POLY. FURTHER, THE SURGEON ALSO STATED THAT THE POST WAS SHEARED OFF. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 16130106 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.