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

Model Number	GLENOID, POLY WITH KEEL, SMALL
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/21/2019
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 the subject underwent a revision rtsa surgery on (b)(6) 2019 where the following hardware was explanted: ar-9104-01 / lot: 160055314.Ide-ar-9300-43cpc / lot: 2501362509.Ide-ar-9343-16 / lot: 1707001.Ide-ar-9301-02 / lot: 2501490914.The reason for the explant is the subject has a complete tear of right rotator cuff.This revision is secondary to a complete rotator cuff tear.The subject has good bone quality.There was no evidence of loosening of the implant.
Additional Manufacturer Narrative
Complaint not confirmed.The failure mode detailed in the event description could not be replicated.Visual evaluation revealed minor superficial scratches along the surface and outer diameter of the glenoid.This is consistent with damage incurred during the removal process.No problem was identified with the returned ar-9104-01 glenoid.

• Brand Name: GLENOID, POLY WITH KEEL, SMALL
• 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: 8349744
• Report Number: 1220246-2019-00911
• Device Sequence Number: 16579412
• Product Code: KWS
• UDI-Device Identifier: 00888867057289
• UDI-Public: 00888867057289
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: 09/03/2021
• Device Model Number: GLENOID, POLY WITH KEEL, SMALL
• Device Catalogue Number: AR-9104-01
• Device Lot Number: 160055314
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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