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

Model Number EQUINOXE REVERSE 42MM HUMERAL LINER +2.5

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2023

Event Type  Injury  

Event Description

It was reported that a 71 yo male patient, initial left shoulder implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 4 months post the initial procedure.The patient was experiencing instability and laxity.The surgeon decided to upsize the liner.The event occurred over time.The patient was revised to an exactech device.The event was not related to a breakage of device.There were no surgical delays.The patient was last known to be in stable condition following the event.No x-rays or device images were able to be obtained.No device returns anticipated due to hospital policies.

Manufacturer Narrative

D10: concomitants: 300-30-08 - equinoxe preserve stem 8mm, 7297782; 320-06-42 - glenosphere 42mm,, (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); 320-15-05 - eq rev locking screw, (b)(6); 320-20-00 - eq reverse torque defining screw kit, (b)(6); 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6); 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6); 531-55-88 - ergo gps 3.2mm drill kit sterile, (b)(6); 531-78-20 - shouldr gps hex pins kit, (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3: 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 patient instability of the shoulder joint devices 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.These devices are used for treatment not diagnosis.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16806725
• MDR Text Key: 313917936
• Report Number: 1038671-2023-00818
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
• Device Catalogue Number: 320-42-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male