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

Catalog Number 320-01-42

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: humeral stem or stemless 3000115.Reverse glenosphere 3200142.Reverse humeral tray 3201000.Reverse glenosphere baseplate 3201503.

Event Description

It was reported via clinical study, that approximately 4 years postop the initial implant, this 77 yo male patient was revised due to disassociation of polyethylene.The patient rolled over in bed and felt a pop.The patient¿s outcome was last known as resolved.The case report form indicates this event is definitely not related to device and definitely not related to procedure.Devices will not be returned.

• Brand Name: EQUINOXE
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17471786
• MDR Text Key: 320519154
• Report Number: 1038671-2023-01882
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086709
• UDI-Public: 10885862086709
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White