MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERDE; REVERSED SHOULDE RPROSTHESIS

Model Number	317-3208
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number (b)(4).
Event or Problem Description
Patient revised on (b)(6) 2021 due to a fall, approximately 5 weeks following primary surgery on (b)(6) 2021.Surgeon replaced the 32/08 cementless hr stem and 36/+6 standard humeral cup with a 32/12 cementless lockable hr stem and 36/+3 standard humeral cup.

• Brand Name: HUMELOCK REVERDE
• Common Device Name: REVERSED SHOULDE RPROSTHESIS
• 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: 12873508
• Report Number: 3009532798-2021-00185
• Device Sequence Number: 11889634
• Product Code: PHX
• UDI-Device Identifier: 03701037303696
• UDI-Public: 03701037303696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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
• Device Model Number: 317-3208
• Device Catalogue Number: 317-3208
• Device Lot Number: N3402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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