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

Catalog Number 311-0310

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Osteolysis (2377)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery occured on (b)(6) 2020 due to loosening, osteolysis of the tuberosities, pseudo-paralysis shoulder.Surgeon explanted all fx components and don't implanted a new fx prothesis.Primary surgery on (b)(6) 2018.

• Brand Name: HUMELOCK II
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: cedric joly ; 1663 rue de de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 9652596
• MDR Text Key: 177383210
• Report Number: 3009532798-2020-10001
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123814
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 311-0310
• Device Lot Number: K1177
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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