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

Catalog Number 300-01-15

Device Problem Defective Device (2588)

Patient Problem Subluxation (4525)

Event Date 05/21/2021

Event Type  Injury  

Event Description

It was reported via clinical study, that approximately 5 years postop the initial implant, this 61 yo male patient was revised due to instability / subluxation.Although this dislocation (instability / subluxation) happened on (b)(6) 2022, this patient was revised on (b)(6) 2023, which is the date this instability / subluxation, indicates was resolved.Devices will not be returned.

Manufacturer Narrative

D10.Concomitants: serial number item number and full description; (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere; (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6) 320-15-03 - rs glenoid plate l post aug, 8 deg, left; (b)(6) 320-38-03 - equinoxe reverse 38mm humeral liner +2.5.

• 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.; FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17599370
• MDR Text Key: 321693306
• Report Number: 1038671-2023-02016
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 08/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2018
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Race: White