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

Model Number EQUINOXE CAGE GLENOID LARGE, BETA

Device Problem Naturally Worn (2988)

Patient Problem Pain (1994)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

Concomitants: 3885932 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.4100198 300-10-45 - equinoxe replicator plate 4.5mm o/s.4238199 300-20-02 - equinox square torque define screw drive kit.2832614 310-01-50 - equinoxe, humeral head short, 50mm (beta).4245253 321-20-00 - equinoxe reverse shoulder drill kit.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported that a patient, initial shoulder implanted on (b)(6) 2016, underwent a revision procedure on (b)(6) 2023, approximately 7 years 8 months post the initial procedure.The patient had presented with pain.The glenoid component was stable but was removed easily except the central cage remained in the bone.A trephine reamer and thread in extractor were used to remove the glenoid.Significant wear of the glenoid was visually confirmed prior to its removal.The stem was planned to be kept, but was found to be loose, so removal was performed and a conversion to a competitor¿s components was done with significant bone grafting on glenoid.There were no issues with the surgery.X-rays and device images provided.Explants are not available for return.Reason unknown.No further information.

• Brand Name: EQUINOXE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 18012426
• MDR Text Key: 326625749
• Report Number: 1038671-2023-02613
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• 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: 10/03/2023
• Date Device Manufactured: 09/29/2015
• 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