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

Catalog Number 311-0210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/04/2021

Event Type  Injury  

Event Description

Patient revised due to infection on (b)(6) 2021, approximately 2 years following primary surgery.Surgeon explanted all components - size 10 cementless humelock ii stem, 2 cortical screws, +0mm double taper, and 43x17 offset cocr head.No new components were implanted.

• Brand Name: HUMELOCK II CEMENTLESS
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS SAS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12868451
• MDR Text Key: 281206568
• Report Number: 3014128390-2021-00061
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 311-0210
• Device Lot Number: N0085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2021
• Distributor Facility Aware Date: 11/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female