MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS SUTURE CUP, 42 (NEUTRAL); PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number UNIVERS REVERS SUTURE CUP, 42 (NEUTRAL)

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 07/20/2020

Event Type  Injury  

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 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 7/22/20: 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.

Manufacturer Narrative

Complaint not confirmed, no abnormalities were observed on the device that may have contributed to the event.

• Brand Name: UNIVERS REVERS SUTURE CUP, 42 (NEUTRAL)
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10366813
• MDR Text Key: 201679805
• Report Number: 1220246-2020-02001
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00888867234253
• UDI-Public: 00888867234253
• Combination Product (y/n): N
• PMA/PMN Number: K161782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: UNIVERS REVERS SUTURE CUP, 42 (NEUTRAL)
• Device Catalogue Number: AR-9502F-42CPC
• Device Lot Number: 170095605
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other