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

Model Number	UNIVERS REVERS SUTURE CUP, 36 (+2 LEFT)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	02/24/2021
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.
Event or Problem Description
It was reported through the surgical outcome system that a pulmonary embolism resulting in inpatient hospitalization occurred during a shoulder arthroplasty procedure in which arthrex product was being used.The patient was treated with concomitant medication.The facility reported that the patient has been discharged from the hospital and is recovering.

• Brand Name: UNIVERS REVERS SUTURE CUP, 36 (+2 LEFT)
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11484308
• Report Number: 1220246-2021-02735
• Device Sequence Number: 19784374
• Product Code: HSD
• UDI-Device Identifier: 00888867234208
• UDI-Public: 00888867234208
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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 LEFT)
• Device Catalogue Number: AR-9502F-36LCPC
• Device Lot Number: 20.01440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other