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

Model Number EQUINOXE CAGE GLENOID LARGE, BETA

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 01/26/2024

Event Type  Injury  

Event Description

It was reported that a patient, initial right shoulder implanted on (b)(6)2014, underwent a revision procedure on (b)(6)2024, approximately 9 years 10 months post the initial procedure.The patient presented with complaints of pain.The glenoid component had migrated from its original position.Significant wear and osteolysis found.Bone grafting and conversion to reverse was performed.There were no issues with the surgery.X-rays were provided.Explanted devices are not available for return.Device images were provided.No further information.

Manufacturer Narrative

Concomitants: 2532751-310-01-53 - equinoxe, humeral head short, 53mm (beta).2719489-300-01-15 - equinoxe, humeral stem primary, press fit 15mm.2770139-314-13-14 - equinoxe cage glenoid large, beta.2840008-300-10-15 - equinoxe replicator plate 1.5mm o/s.Additional information, including the product investigation, will be submitted within 30 days of receipt.

• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18803637
• MDR Text Key: 336507987
• Report Number: 1038671-2024-00336
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: EQUINOXE CAGE GLENOID LARGE, BETA
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Date Device Manufactured: 08/02/2013
• 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