MAUDE Adverse Event Report: ARTHREX, INC. 36 +4 LAT/24 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 36 +4 LAT/24 GLENOSPHERE

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 11/05/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, it was reported by a sales representative via phone that an ar-9564-2436-lat glenosphere (line #1) and an ar-9503s-03 humeral cup (line #2) were explanted on (b)(6) 2021 due to a dislocation, caused by a fall.The date of the primary procedure was on (b)(6) 2021 and took place at university of maryland rehabilitation and orthopedic institute, arthrex account #:(b)(4) (b)(6).The ar-9564-2439-lat glenoshpere, ar-9503-3639-3c combo humeral insert, and ar-9555-09 spacer, were implanted during the reported revision surgery.The ar-9503-3639-6c humeral insert was implanted then explanted as the device was the incorrect size.

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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: 36 +4 LAT/24 GLENOSPHERE
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 12853717
• MDR Text Key: 281140210
• Report Number: 1220246-2021-03986
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867295681
• UDI-Public: 00888867295681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 36 +4 LAT/24 GLENOSPHERE
• Device Catalogue Number: AR-9564-2436-LAT
• Device Lot Number: 20.02563
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2021
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other