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

Model Number 311-0212

Device Problems Output Problem (3005); Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2021

Event Type  Injury  

Event Description

Patient was revised on (b)(6) 2021 due to cuff tear, approximately 5 years after the first surgery.The surgeon explanted stem ta6v size 12, double taper, centered head, two cortical screw, offset modular system and hex screw.The surgeon implanted stem ta6v size 10, humeral cup 36+6, glenoid baseplate, two locking screw and screw.

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.

• Brand Name: HUMELOCK II ANATOMIC
• Type of Device: METALLIC UNCEMENTED SHOULDER PROSTHESIS
• 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: 13083522
• MDR Text Key: 282772597
• Report Number: 3009532798-2021-00183
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• 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: 12/23/2021

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 Model Number: 311-0212
• Device Catalogue Number: 311-0212
• Device Lot Number: J1245
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/24/2021
• 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