MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID LARGE, BETA

Catalog Number 314-13-14

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

Patient Problem Failure of Implant (1924)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): humeral stem, replicator plate, torque screw, humeral head.

Event Description

As reported by the equinoxe shoulder study, this (b)(6) male 5¿8¿, wt.(b)(6) patient had an initial right tsa on (b)(6) 2012.The patient was revised on (b)(6) 2019 for aseptic glenoid loosening of right shoulder tsa.According to the report, the event is possibly related to the device and definitely related to the procedure.

Manufacturer Narrative

Section h10: (d4) catalog number: 314-13-14, serial number: (b)(6), expiration date: 21-oct-2017, unique identifier (udi) #: (b)(4).(g5) pma/510(k) number: k113309, (h4) device manufacture date: 24-oct-2012.Section h11: *the following sections have corrected information: (d2) cage glenoid large, beta (d11) concomitant device(s): 300-01-13, 2455686 - equinoxe, humeral stem primary, press fit 13mm; 300-20-02, 2504677 - equinox square torque define screw drive kit; 300-10-45, 2502584 - equinoxe replicator plate 4.5mm o/s; 310-01-50, 2358969 - equinoxe, humeral head short, 50mm (beta).*no information provided in the following section(s): b6, g8, h7, h9.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the glenoid component.However, this cannot be confirmed because the explanted devices were not available for evaluation.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID LARGE, BETA
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9521279
• MDR Text Key: 173021762
• Report Number: 1038671-2019-00635
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2017
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91