MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS CEMENTLESS REVERSIBLE; METALLIC UNCEMENTED PROSTHESIS

Model Number	313-0903
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient revised on (b)(6) 2021 due to instability, approximately 4.5 months following primary surgery on (b)(6) 2021.Surgeon explanted the 135/145 36/+3 stability humeral cup and replaced it with a 36/+6 stability humeral cup and a 135/145 reversed adapter for an extra +9mm of spacing.
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00055.

• Brand Name: HUMERIS CEMENTLESS REVERSIBLE
• Common Device Name: METALLIC UNCEMENTED 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: 12923438
• Report Number: 3009532793-2021-00186
• Device Sequence Number: 4869671
• Product Code: HSD
• UDI-Device Identifier: 03701037310526
• UDI-Public: 03701037310526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193394
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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 Expiration Date: 02/01/2026
• Device Model Number: 313-0903
• Device Catalogue Number: 313-0903
• Device Lot Number: P0833
• 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: 12/03/2021
• 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