MAUDE Adverse Event Report: EXACTECH, INC. SHOULDER GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): tray liner.Torque screw.

Event Description

It was reported that this males patient's shoulder was revised.Parts were all intact, surgeon replaced parts for bigger glenosphere, liner and tray.Patient was last known to be in stable condition following the event.Product not being returned due to policy.

• Brand Name: SHOULDER GLENOSPHERE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17257045
• MDR Text Key: 318449108
• Report Number: 1038671-2023-01534
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Sex: Male