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

Model Number	317-3208
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to stem loosening on (b)(6) 2022, following the primary surgery on (b)(6) 2021.The surgeon explanted the humelock reversed stem (32/08), a taper adapter (24/10) and offset head (46x18).A humelock reversed stem (32/10), a taper adapter (24/10) and offset head (46x18) were implanted.This event has been filed by the manufacturer under the report number 3009532798-2022-00128.

• Brand Name: HUMELOCK ANATOMIC
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 15455507
• Report Number: 3014128390-2022-00023
• Device Sequence Number: 15206478
• Product Code: HSD
• UDI-Device Identifier: 03701037303696
• UDI-Public: 03701037303696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2022
• Report Date (Section F): 09/07/2022

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
• Operator of Device: Health Professional
• Device Model Number: 317-3208
• Device Catalogue Number: 317-3208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/07/2022