MAUDE Adverse Event Report: ARTHREX, INC. 39 +4 LAT/28 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	39 +4 LAT/28 GLENOSPHERE
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/25/2021
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 patient experienced an infection after undergoing a shoulder arthroplasty procedure causing the need for implant removal.The primary procedure took place on (b)(6) 2020.The revision surgery was performed by the same surgeon who performed the primary and took place at the same facility as the original surgery.The revision took place on (b)(6) 2021.The part and lot numbers of explanted arthrex material is currently unknown.The patient was revised with hemi-arthroplasty, using arthrex apex.Additional information received on 4/9/2021: the rep provided the part/lot numbers of explanted arthrex product that was removed during the revision surgery.See explanted material listed below; ar-9561-25p / lot: 8013, ar-9560-28-4 / lot: 6807, ar-9501-06s / lot: 19.03511, ar-9502f-39lcpc / lot: 19.02275, ar-9564-2839-lat / lot: 19.01015, ar-9564-2839 / lot: 19.00603, ar-9562-28nl / lot: 18.00143, ar-9503m-03 / lot: 18.01724, ar-9505-06 / lot: 19.03720, ar-9563-28 / lot: 2019003486 (x 2), ar-9562-28nl / lot: 2019001689.

• Brand Name: 39 +4 LAT/28 GLENOSPHERE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11730992
• Report Number: 1220246-2021-02980
• Device Sequence Number: 4253788
• Product Code: PHX
• UDI-Device Identifier: 00888867295797
• UDI-Public: 00888867295797
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/27/2021

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: 39 +4 LAT/28 GLENOSPHERE
• Device Catalogue Number: AR-9564-2839-LAT
• Device Lot Number: 19.01015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other