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

Model Number 313-0903

Device Problem Unstable (1667)

Patient Problem Joint Laxity (4526)

Event Date 10/27/2021

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 281680522
• Report Number: 3009532793-2021-00186
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037310526
• UDI-Public: 03701037310526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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 Model Number: 313-0903
• Device Catalogue Number: 313-0903
• Device Lot Number: P0833
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization