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

Model Number	GLENOSPHERE 42MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/08/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1038671-2022-00948
• Device Sequence Number: 17589348
• Product Code: KWT
• UDI-Device Identifier: 10885862563712
• UDI-Public: 10885862563712
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White