MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGE GLENOID M, POST AUG, RIGHT

Catalog Number 314-13-33

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

Patient Problem Failure of Implant (1924)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): humeral stem or stemless (cat# 300-01-11).Humeral head (cat# 310-01-44).Replicator plate (cat# 300-10-45).

Event Description

As reported by the equinoxe shoulder study, the patient experienced gross loosening of glenoid component with two (2) metallic pegs displaced anterior and inferiorly.Polyethylene component appears disassociated from the cage as the head is sitting on the native glenoid.A revision was completed on (b)(6) 2019 and a standard reverse tsa was implanted.Non-structural graft.Cancellous chips and optecure to fill contained/small uncontained defect.The pathology report showed no evidence of acute inflammation.The report noted the event is possibly related to the device and to the procedure.

Manufacturer Narrative

Section h10: (h3) the revision due to glenoid loosening and disassociation of the metal pegs from the polyethylene body of the glenoid component reported is likely due to drilling the peripheral peg holes at an angle or not fully seating the cage glenoid component at the time of implantation.However, this cannot be confirmed because the component was not returned for evaluation and radiographs were not provided.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID M, POST AUG, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9521331
• MDR Text Key: 173024875
• Report Number: 1038671-2019-00636
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• 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
• Report Date: 04/21/2020

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 Catalogue Number: 314-13-33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 77