MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE 42MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOSPHERE 42MM

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

Patient Problem Bone Fracture(s) (1870)

Event Date 06/08/2021

Event Type  Injury  

Event Description

It was reported via clinical study, equinoxe shoulder study, that a 69 yo caucasian female, height 70 in., weight 177 lbs., bmi 25, who was initially implanted on the left side on (b)(6) 2021 for a preoperative diagnosis of osteoarthritis reported they felt popping while they slept.There were no symptoms noted on x-ray.Scapular spine fracture, (type 2).Date of onset (b)(6) 2021.No medication, revision, or other actions taken.The case report form indicates this event is possibly related to devices and definitely related to procedure.Outcome reported resolved on (b)(6) 2021.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the scapular spine fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and possibly related to surgical procedure.

Manufacturer Narrative

Concomitants: 300-01-13 equinoxe, humeral stem primary, press fit 13mm; 320-42-00 equinoxe reverse 42mm humeral liner +0; 320-10-00 equinoxe reverse tray adapter plate tray +0; 320-15-01 eq rev glenoid plate.Device remains implanted.

Manufacturer Narrative

Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the scapular spine fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and possibly related to surgical procedure.

• Brand Name: GLENOSPHERE 42MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15260482
• MDR Text Key: 298285663
• Report Number: 1038671-2022-00948
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862563712
• UDI-Public: 10885862563712
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOSPHERE 42MM
• Device Catalogue Number: 320-06-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White