MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 7; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 7
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
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
The patient had a reverse shoulder done on (b)(6) 2019.She was having inflammation problems at the site; there was another case done on (b)(6) 2021 to remove the devices.They checked for infection; tests were negative.The surgeon determined that the stem and cup were loose; they were removed from the patient.A size 8 stem and cup were inserted into the patient for a total shoulder repair.
Additional Manufacturer Narrative
Complaint not confirmed, no abnormality or damage was observed on the device.The ar-9502f-36cpc cup and screw returned were assembled and seated without difficulty.The cause of the event is undetermined.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11947503
• Report Number: 1220246-2021-03222
• Device Sequence Number: 16488119
• Product Code: HSD
• UDI-Device Identifier: 00888867250390
• UDI-Public: 00888867250390
• 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,Followup
• Report Date (Section B): 07/12/2021

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 Expiration Date: 04/30/2023
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 7
• Device Catalogue Number: AR-9501-07P
• Device Lot Number: 18.00049
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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