MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, POLY WITH KEEL, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOID, POLY WITH KEEL, LARGE
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	07/22/2019
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 that the patient underwent a revision procedure on (b)(6) 2019 where the glenoid poly w/ keel, ar-9104-03, was explanted.The patient suffered a rotator cuff tear however, the failure is not related to the implant.The following was also implanted: ide-ar-9300-49cpc / lot: 150070712; ide-ar-9301-03 / lot: 160109817; ide-ar-9349-20 / lot: 1706002.Additional information provided (b)(6) 2019: after the original procedure, the patient presented with pain and limited range of motion.An mri was ordered and uncovered a rotator cuff tear.The revision was performed at the same facility with the same surgeon as the first surgery.The following devices were implanted during the revision: ar-9560-28-4 / lot: 5662; ar-9561-35s / lot: 5690; ar-9564-2842-lat / lot: 18.01739; ar-9563-28 / lot: 2019000055 x3; ar-9563-28 / lot: 2018035253; ar-9501-13s / lot: 18.00400; ar-9502f-42cpc / lot: 18.01658; ar-9503l-06 / lot: 19.00081.Additional information provided (b)(6) 2019: the date of the first surgery was (b)(6) 2018.

• Brand Name: GLENOID, POLY WITH KEEL, LARGE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8887273
• Report Number: 1220246-2019-01244
• Device Sequence Number: 19479692
• Product Code: KWS
• UDI-Device Identifier: 00888867057302
• UDI-Public: 00888867057302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K010124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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 Expiration Date: 08/02/2021
• Device Model Number: GLENOID, POLY WITH KEEL, LARGE
• Device Catalogue Number: AR-9104-03
• Device Lot Number: 160042815
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other