MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II; SHOULDER PROTHESIS

Model Number 311-0210

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Injury (2348)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

Patient revised on (b)(6) 2020 due to a cuff tear.Cementless size 10 humeral steam, double tapper, cortical screw and size 43 centered humeral head were removed and replaced by size 8 cemented steam, glenoid baseplate, 36 glenosphere, 36/+6 humeral cup and associated screws.Primary surgery on (b)(6) 2019.

• Brand Name: HUMELOCK II
• 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: cedric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10640827
• MDR Text Key: 210270545
• Report Number: 3009532798-2020-00446
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 311-0210
• Device Lot Number: M1216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2018
• 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