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

Model Number	GLENOSPHERE 38MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (b)(4), 300-30-07 - equinoxe preserve stem 7mm, (b)(6) 2021; (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(6) 2021; (b)(4), 320-15-04 - rs glenoid plate r post aug, 8 deg, right, (b)(6) 2021; (b)(4), 320-15-05 - eq rev locking screw, (b)(6) 2021; (b)(4), 320-20-00 - eq reverse torque defining screw kit, (b)(6) 2021; (b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6) 2021; (b)(4), 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, (b)(6) 2021; (b)(4), 320-38-00 - 145-deg pe 38mm hum liner +0, (b)(6) 2021; (b)(4), 531-78-20 - shouldr gps hex pins kit, (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 surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Infection is a clinically well-known potential complication of any surgical procedure including shoulder arthroplasty.
Event or Problem Description
It was reported that a 65 yo male patient, had an initial right shoulder implanted on (b)(6)2021, and then underwent a revision procedure on (b)(6) 2022, approximately 1 year 4 months post the initial procedure.The patient had a suspected infection.I&d was done and liner and glenosphere were replaced.The patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation during the revision procedure.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.The devices will not to be returned due to hospital policy.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4, g4, h4, h6, h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A review of complaint history determined that no further action is required as no trends were identified.A definitive root cause was unable to be determined; however, may have resulted from the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Infection is a clinically well-known potential complication of any surgical procedure including shoulder arthroplasty.These devices are used for treatment not diagnosis.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• 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: 16195962
• Report Number: 1038671-2023-00043
• Device Sequence Number: 5971057
• Product Code: KWT
• UDI-Device Identifier: 10885862563699
• UDI-Public: 10885862563699
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 38MM
• Device Catalogue Number: 320-06-38
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male