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

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

Device Problem Naturally Worn (2988)

Patient Problem Osteolysis (2377)

Event Date 12/08/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: concomitants: 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, 1907518, 320-01-38 - equinoxe reverse 38mm glenosphere, 1992020, 320-10-05 - equinoxe reverse tray adapter plate tray +5, 1817829, 320-15-01 - eq rev glenoid plate, 1973090, 320-15-05 - eq rev locking screw, 1996212, 320-20-00 - eq reverse torque defining screw kit, 1998732, 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, 2002255, 2002257, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, 1848305, 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, 1921521, 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm, 1990815, additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a 69 yo female patient, initial right shoulder implanted on (b)(6) 2011, underwent a revision procedure on (b)(6) 2022, approximately 11 years 8 months post the initial procedure.The patient had osteolysis of the proximal humerus due to poly wear from the humeral liner.Patient had instability due to soft tissue and bone loss from the poly wear.They revised the patient with a new humeral liner, humeral adapter tray and new glenosphere.The patient was last known to be in stable condition following the event.The devices are not available for return as the hospital will not release them.

• Brand Name: EQUINOXE REVERSE
• 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: 16069135
• MDR Text Key: 306347216
• Report Number: 1038671-2022-01641
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2015
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Date Device Manufactured: 07/21/2010
• 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
• Patient Age: 69 YR
• Patient Sex: Female