MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE, 36MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-31-36

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 08/14/2023

Event Type  Injury  

Event Description

It was reported that this female patient had a left shoulder revision surgery on (b)(6) 2023 due to dislocation that occurred prior to a fall/post traumatic event.Post revision hrp reverse tsa surgery, the patient returned to surgeons office for follow-up.Imaging was taken at the follow-up post-revision surgery and it showed early scapular notching with bone changes behind the glenoid implant.The patient is currently stable.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 320-10-00: equinoxe reverse tray adapter plate tray +0 (b)(6), exp.7/18/2033.320-20-00: eq reverse torque defining screw kit (b)(6), exp.6/12/2028.320-40-03: 145-deg pe 40mm hum liner +2.5 (b)(6), exp.5/24/2026.320-15-05: eq rev locking screw (b)(6), exp.5/23/2028.320-31-40: glenosphere, 40mm (b)(6), exp.3/9/2031.320-40-13: 145-deg pe 40mm const hum liner +2.5 (b)(6), exp.1/23/2025.

• Brand Name: GLENOSPHERE, 36MM
• 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 ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18083013
• MDR Text Key: 327481848
• Report Number: 1038671-2023-02694
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-31-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2023
• 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: SEE H10.
• Patient Sex: Female