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

Model Number 314-13-23

Device Problems Loss of Osseointegration (2408); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Primary surgery: (b)(6) 2019.Surgeon had to do surgery on a patient with nonunion of the tub.Minus on left shoulder.He treated the nonunion without complications.While he was doing so, he realized that the poly of the glenoid was loose.The cage and two pegs where tightly connected to the bone; one peg was still connected to the poly but not integrated in the bone.The poly was sheered of the cage and the two integrated pegs.

Manufacturer Narrative

Section h10: (d4) serial number: (b)(6), expiration date: 18-mar-2020.(d8) is this a single-use device that was reprocessed and reused on a patient?: no.(e3) occupation: physician.(g5) pma/510(k)number: k113309.(h3) the revision reported was likely the result nonunion.The reported loosening may have either been the result of drilling the peripheral peg holes at an angle or not fully seating the cage glenoid component at the time of implantation, which led to the disassociation of the metal pegs from the polyethylene body of the glenoid component.However, this cannot be confirmed because the component was not returned for evaluation and x-rays were not provided.(h4) device manufacture date: 25-mar-2015.(h6) evaluation codes: 1924, 4002 section h11: the following sections have corrected information: (h5) labeled for single use?: yes.

• Brand Name: EQUINOXE
• Type of Device: CAGE GLENOID M, POST AUG, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8837795
• MDR Text Key: 152535002
• Report Number: 1038671-2019-00378
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2020
• Device Model Number: 314-13-23
• Device Catalogue Number: 314-13-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention