MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK; SHOULDER PROSTHESIS

Model Number DIAMETER 46 mm OFFSET

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Rupture (2208)

Event Date 02/26/2021

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

Revision surgery due to a heavy rupture of the supraspinatus occured on (b)(6) 2021.Double taper, ø46 eccentric head, ø36 cage and associated screws were removed and replaced by ø24 baseplate, ø36 eccentric glenosphere, 135/145° standard humeral cup and associated screws.

• Brand Name: HUMELOCK
• Type of Device: 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: 11641735
• MDR Text Key: 244661745
• Report Number: 3009532798-2021-00040
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300497
• UDI-Public: 03701037300497
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• 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: 04/07/2021

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: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: DIAMETER 46 mm OFFSET
• Device Catalogue Number: 106-4600
• Device Lot Number: L1263W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2018
• 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