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

Catalog Number 314-13-34

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 05/29/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant devices: equinoxe preserve stem 12mm (cn# 300-30-12); equinoxe, humeral head expanded, 50mm (beta) (cn# 310-03-50); equinoxe replicator plate 4.5mm o/s (cn# 300-10-45).

Event Description

It was reported that a male patient received a right shoulder arthroplasty on (b)(6) 2019.Patient was then revised due to instability/subluxation.

Manufacturer Narrative

Section h10: (g5) pma/510(k)number: k113309.(h3) device was used for treatment, not diagnosis.There is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event, instability/subluxation, is related to the underlying patient conditions.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID L, POST AUG, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9034124
• MDR Text Key: 162340164
• Report Number: 1038671-2019-00449
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (y/n): N
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 68