MAUDE Adverse Event Report: ZIMMER BIOMET ALLLIANCE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number ALLIANCE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Zimmer alliance glenoid inserter piece broke off undetected and was retained in patient.Patient returned to or to have metal removed.Metal was subcutaneous and easily removed.The patient suffered moderate harm due to needing a second anesthetic event.Manufacturer response for zimmer alliance glenoid inserter, allliance (per site reporter).They want us to return it to them.

• Brand Name: ALLLIANCE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET; 1800 west center street; warsaw IN 46580
• MDR Report Key: 18434471
• MDR Text Key: 331774271
• Report Number: 18434471
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2023,12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ALLIANCE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Female