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

Model Number 317-3208

Device Problem Loss of Osseointegration (2408)

Patient Problem Joint Laxity (4526)

Event Date 08/22/2022

Event Type  Injury  

Event 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
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 15455507
• MDR Text Key: 300240329
• Report Number: 3014128390-2022-00023
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037303696
• UDI-Public: 03701037303696
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Report Sent to FDA: 09/07/2022
• Distributor Facility Aware Date: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female