MAUDE Adverse Event Report: ARTHREX, INC. 24MM BASEPLATE, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number 24MM BASEPLATE, MODULAR

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 02/26/2021

Event Type  Injury  

Event Description

It was reported through the surgical outcome system that a revision surgery is required due to the loosening of an arthrex prosthetic joint.The primary surgery took place on (b)(6) 2020.The complication was reported on (b)(6) 2020; indicating loosening of prosthetic joint and a revision required.The revision surgery took place on (b)(6) 2021.The following arthrex product was explanted during the revision surgery; ar-9560-24 (lot: 5655).Ar-9561-20p (lot: 7038).Ar-9562-36nl (lot: 2018005757).Ar-9562-40nl (lot: 2018001457).Ar-9563-20 (lot: 2019003063).Ar-9564-2436-lat (lot: 19.03388).Ar-9502f-36rcpc (lot: 19.00394).Ar-9503s-06 (lot: 170052510).The following arthrex product was implanted during the revision surgery; ar-9502f-36rcpc (lot: 20.01053).Ar-9555-06 (lot: 170143213).Ar-9503s-06 (lot: 20.01369).

• Brand Name: 24MM BASEPLATE, MODULAR
• 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: 11485611
• MDR Text Key: 239831072
• Report Number: 1220246-2021-02754
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867296411
• UDI-Public: 00888867296411
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24MM BASEPLATE, MODULAR
• Device Catalogue Number: AR-9560-24
• Device Lot Number: 5655
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/28/2021
• Initial Date Manufacturer Received: 02/28/2021
• Initial Date FDA Received: 03/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other