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 Code	Foreign Body In Patient (2687)
Date of Event	01/09/2019
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 requested/is expected but has 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 in an (b)(6) study, the large glenoid poly with keel, ar-9104-03, was explanted due to rotator cuff dysfunction with proximal humeral migration in the left shoulder.The subject ((b)(6)) received a revers total shoulder after the explant.The explanted hardware is as follows: device part numbers and lots: univers glenoid: ref ar-9104-03, lot 160055515.Arthrex eclipse humeral head: ref ide-ar-9349-18, lot 1419036.Arthrex eclipse hollow screw, medium, uncemented: ref ide-ar-9301-02, lot 2501490914.Arthrex eclipse trunion, tps cap coated 49mm: ref ide-ar-9300-49cpc, lot 150070712.
Additional Manufacturer Narrative
Complaint was not confirmed.The failure mode detailed in the event description could not be replicated.No problem was identified with the returned ar-9104-03 device.

• 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: 8289613
• Report Number: 1220246-2019-00874
• Device Sequence Number: 2141693
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 09/21/2021
• Device Model Number: GLENOID, POLY WITH KEEL, LARGE
• Device Catalogue Number: AR-9104-03
• Device Lot Number: 160055515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1