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

Catalog Number 314-13-02

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/29/2024

Event Type  Injury  

Event Description

As reported, the patient had an initial right tsa in 2019.The patient's glenoid implant fractured and the poly sheared off.The patient was revised on (b)(6) 2024.One peg and cage also dissociated and were removed.Metallosis was seen, most likely due to the pegs/cage being exposed to the head.The stem was loose as well.Explanted all hardware and revised to an antibiotic spacer.All parts/pieces were removed from the patient.There was a 45 minute surgical delay, but no adverse events as a result.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

Manufacturer Narrative

H3: pending investigation.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• 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; gainesville FL 32653
• Manufacturer Contact: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18682445
• MDR Text Key: 335071132
• Report Number: 1038671-2024-00201
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 64 YR
• Patient Sex: Female