MAUDE Adverse Event Report: ARTHREX, INC. 20MM CENTRAL POST, MODULAR; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	20MM CENTRAL POST, MODULAR
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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: 20MM CENTRAL POST, MODULAR
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11484738
• Report Number: 1220246-2021-02744
• Device Sequence Number: 17094929
• Product Code: PHX
• UDI-Device Identifier: 00888867296510
• UDI-Public: 00888867296510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 20MM CENTRAL POST, MODULAR
• Device Catalogue Number: AR-9561-20P
• Device Lot Number: 7038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other