MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 6; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 6
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	07/20/2020
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 a patient underwent a univers revers total shoulder procedure (b)(6) 2019.The patient was experiencing post op pain and an infection.The original surgeon performed a second surgery at the same facility (b)(6) 2020.During the second surgery the following original arthrex products were explanted: ar-9501-06p, univers revers stem, lot 18.01910, ar-9502f-42cpc, univers revers suture cup, lot 170095605, ar-9502-42arca, revers adapter assembly, lot 241624, ar-9556-22rca, revers ca humeral head, lot 10165385.The explanted devices will be returned for evaluation.Additional information obtained 07/22/2020: the glenoid implants from the original procedure were left in the patient.The only devices explanted were the above listed implants.The specific type of infection or any culture results are not being provided to the sales rep.
Additional Manufacturer Narrative
Complaint not confirmed, no abnormalities were observed on the device that may have contributed to the event.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 6
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10366801
• Report Number: 1220246-2020-02000
• Device Sequence Number: 11574845
• Product Code: HSD
• UDI-Device Identifier: 00888867249264
• UDI-Public: 00888867249264
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 01/31/2024
• Device Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 6
• Device Catalogue Number: AR-9501-06P
• Device Lot Number: 18.01910
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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