MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE 145-DEG PE 46MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-46-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm: 6726262; 320-01-46 - equinoxe reverse 46mm glenosphere: 4405310; 320-15-01 - eq rev glenoid plate: 6589233; 320-15-05 - eq rev locking screw: 6744086; 320-20-00 - eq reverse torque defining screw kit: 6369627; 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: s128309; 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: s128349; 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: 6210169; 321-20-00 - equinoxe reverse shoulder drill kit: 6715096.
Event or Problem Description
Approximately 3 year(s), 8 month(s) and 13 day(s) post-operative of a left rtsa, it was reported via clinical study that the patient experienced disassociation of polyethylene.Subject was golfing, heard popping and pain.The patient underwent a standard reverse with preserve stem revision with the removal of the preserve stem (rtsa), humeral tray, humeral liner, glenosphere, glenosphere locking screw, and glenoid base plate.The outcome of this event is considered resolved and the clinical report indicates that this event is definitely related to the device(s) and definitely not related to the procedure.

• Brand Name: EQUINOXE 145-DEG PE 46MM HUM LINER +0
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20280052
• Report Number: 1038671-2024-03658
• Device Sequence Number: 7545960
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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 Expiration Date: 06/24/2025
• Device Catalogue Number: 320-46-00
• 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: 09/10/2024
• Initial Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 06/26/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White