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

Model Number	Ø36/12 CEMENTLESS LOCKABLE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00080.
Event or Problem Description
The patient was revised on (b)(6) 2021, approximately 11 months after the primary surgery on (b)(6) 2021.The revision was due to dislocation resulting from the wear & tear in the humeral cup.The surgeon explanted the standard humeral cup (36/+3) and implanted a stability humeral cup (36/+6).

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• 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: 13385380
• Report Number: 3009532798-2021-00270
• Device Sequence Number: 14583796
• Product Code: PHX
• UDI-Device Identifier: 03701037303740
• UDI-Public: 03701037303740
• 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): 01/17/2022

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
• Device Expiration Date: 05/01/2025
• Device Model Number: Ø36/12 CEMENTLESS LOCKABLE
• Device Catalogue Number: 317-3612
• Device Lot Number: N3404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2021
• Initial Report FDA Received Date: 01/28/2022
• 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