MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROTHESIS

Model Number 106-4300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 07/08/2020

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2020, approximately 15 months after the primary surgery on (b)(6) 2019.According to the field representative, the patient needed to have a muscle transfer done due to a brachial plexus injury and was not a candidate for a reverse prosthesis.In order to make room in the joint for the transfer, the surgeon explanted the 43x17 offset cocr head and +0mm double taper, and replaced them with a 41x16 offset cocr head and a new +0mm double taper.

• Brand Name: HUMERIS
• Type of Device: SHOULDER PROTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: cédric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10338241
• MDR Text Key: 200799060
• Report Number: 3009532798-2020-00300
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2020

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: 05/01/2023
• Device Model Number: 106-4300
• Device Lot Number: M1046
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention