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

Model Number	311-0212
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside the united stated (in france) and was associated with a product that is also cleared for the market in the united states.
Event or Problem Description
The patient was revised due to a revision for infection on (b)(6) 2022.The implantation date was on (b)(6) 2022 (date unknown).A cup, a glenosphere, a metaglene and a stem were explanted.No implant was implanted.

• Brand Name: HUMELOCK II REVERSED
• Common Device Name: REVERSED 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: 16146789
• Report Number: 3009532798-2023-00002
• Device Sequence Number: 6867408
• Product Code: PHX
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/11/2023

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: 01/01/2023
• Device Model Number: 311-0212
• Device Catalogue Number: 311-0212
• Device Lot Number: M2232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/12/2023
• 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