MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED ANATOMIC; UNCEMENTED SHOULDER PROTHESIS

Model Number 317-3208

Device Problem Loss of Osseointegration (2408)

Patient Problem Joint Laxity (4526)

Event Date 08/22/2022

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number 3014128390-2022-00023.

Event Description

The patient was revised on (b)(6) 2022 due to loosening, approximately 392 days after the first surgery.The surgeon explanted 1 stem 32/08, 1 taper adaptater, 1 head.The surgeon implanted 1 stem 32/10, 1 taper adaptater, 1 head.

• Brand Name: HUMELOCK REVERSED ANATOMIC
• Type of Device: UNCEMENTED SHOULDER PROTHESIS
• 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: 15389153
• MDR Text Key: 299558834
• Report Number: 3009532798-2022-00128
• 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: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization