MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/04/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient had a reverse shoulder case done in (b)(6) 2020.Due to infections, all the devices were removed on (b)(6) 2021.An antibiotic spacer was placed at the site; there may be a shoulder revision done in the future.Removed ar-9501-05p, ar-9502f-36rcpc, ar-9564-2433-lat, ar-9503-3633-3c, ar-9560-24, ar-9561-30s.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11871891
• Report Number: 1220246-2021-03134
• Device Sequence Number: 10993517
• Product Code: HSD
• UDI-Device Identifier: 00888867234215
• UDI-Public: 00888867234215
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/24/2021

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: UNIVERS REVERS SUTURE CUP, 36 (+2 RIGHT)
• Device Catalogue Number: AR-9502F-36RCPC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/24/2021
• 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