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

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
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2022-00023.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3009532798-2022-00128
• Device Sequence Number: 5567134
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2022

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 Expiration Date: 04/01/2026
• Device Model Number: 317-3208
• Device Catalogue Number: 317-3208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown