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

Model Number	RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: (b)(6) 320-15-05 - eq rev locking screw; (b)(6) 320-15-05 - eq rev locking screw; (b)(4) 320-38-13 - equinoxe reverse 38mm humeral const liner +2.5.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 dislocation 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 [poor bone quality], unique anatomy, or other condition that impacts the performance of the device.Device specific risks includes dislocation of the prosthesis or any of its components which may require a second surgical intervention or revision.
Event or Problem Description
It was reported that an 89 yo female patient, initial right shoulder implanted on (b)(6)2022 , underwent a revision procedure on (b)(6)2022 , approximately 5 months post the initial procedure due to dislocation, scapular notching indicated as the reason.The patient was revised to exactech devices.No breakage of device or surgical delay/prolongation reported.The patient required prolonged hospitalization as a direct result of this issue.The devices will not to be returned due to being discarded by the hospital.No additional information.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 16140987
• Report Number: 1038671-2023-00034
• Device Sequence Number: 6704533
• Product Code: KWS
• UDI-Device Identifier: 10885862186751
• UDI-Public: 10885862186751
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 01/11/2023

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: RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
• Device Catalogue Number: 320-02-38
• 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: 12/22/2022
• Initial Report FDA Received Date: 01/11/2023
• Date Device Manufactured: 06/22/2020
• 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: 89 YR
• Patient Sex: Female