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

Model Number 314-13-03

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/28/2022

Event Type  Injury  

Event Description

As reported by the equinoxe shoulder study, approximately 5 years post op the initial tsa, this 62 y/o female patient was experiencing aseptic glenoid loosening.Gross loosening at 5 year visit.Possibly exacerbated from fall 6 weeks prior.The case report form does indicate this event is definitely related to devices and possibly procedure.This event report was received through clinical data collection activities.Outcome is continuing, medication, revision recommendation, ct scan ordered.

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-01-09 - equinoxe, humeral stem primary, press fit 9mm, sn: (b)(4); 300-10-45 - equinoxe replicator plate 4.5mm o/s, sn: (b)(4); 300-20-02 - equinox square torque define screw drive kit, sn: (b)(4); 310-02-41 - equinoxe, humeral head tall, 41mm (alpha), sn: (b)(4); 315-35-00 - glnd kwire, sn: (b)(4); 620-00-02 - platelet rich plasma kit with spray tips, sn: (b)(4); 620-12-02 - accelerate prp 60 ml & acd-a, sn: (b)(4).

Manufacturer Narrative

Section h10: (h3) the revision reported in (b)(4) was likely the result of the superior peripheral peg and center cage sitting proud at the time of implantation and a post traumatic event, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices were not available for evaluation.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15340961
• MDR Text Key: 299151928
• Report Number: 1038671-2022-01004
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• 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: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Model Number: 314-13-03
• Device Catalogue Number: 314-13-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White