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

Catalog Number 311-0210

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/06/2021

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 for postop fracture on (b)(6) 2021.Approximately 2 years after the first surgery.The surgeon explanted centered head, double taper and humelock ii stem size 11.For the replaced product was not fx solutions product.

• Brand Name: HUMELOCK II
• Type of Device: PROSTESIS SHOULDER
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12679669
• MDR Text Key: 277864245
• Report Number: 3009532798-2021-00152
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2021

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
• Device Operator: No Information
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 311-0210
• Device Lot Number: N1812
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization