MAUDE Adverse Event Report: ARTHREX, INC. VIP GLENOID 3D MODEL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number VIP GLENOID 3D MODEL

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported, that the ar-vip3d model and the targeted legs did not match up at all.The surgeon was not pleased with this plan.The rep reported it was almost like the model anatomy did not match the patients.The model is returning.Additional information received on 10/6/2020: the rep reported the surgery was not rescheduled but the issue with the model caused the surgeon to have to freehand the guide pin.

• Brand Name: VIP GLENOID 3D MODEL
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10730523
• MDR Text Key: 213017940
• Report Number: 1220246-2020-02255
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867335769
• UDI-Public: 00888867335769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIP GLENOID 3D MODEL
• Device Catalogue Number: AR-VIP3D
• Device Lot Number: 1220080016
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other