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

Catalog Number 311-0210

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/04/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event Description

Patient was revised on (b)(6) 2021 due to a infection, approximately 2 years after the first surgery.The surgeon explanted size 10 cementless humelock ii stem, cortical screw (d= 4.5mm l=28mm), double taper and 43*17 offset cocr head.No information on the implanted products.

• Brand Name: HUMELOCK II CEMENTLESS
• Type of Device: METALLIC UNCEMENTED PROSTHESIS 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: 13010734
• MDR Text Key: 282322675
• Report Number: 3009532798-2021-00200
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 311-0210
• Device Lot Number: N0085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• 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