MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS REVERSED; UNCEMENTED SHOULDER PROTHESIS

Model Number 313-0706

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Date 06/08/2022

Event Type  Injury  

Event Description

The patient was revised on (b)(6) 2022 due to instability, approximately 1170 days after the first surgery.The surgeon explanted 1 humeral cup 36+6.The surgeon implanted 1 reversed adapter and 1 humeral cup 36+9.

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number 3014128390-2022-00021.

• Brand Name: HUMERIS REVERSED
• Type of Device: UNCEMENTED 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: 15155495
• MDR Text Key: 297135516
• Report Number: 3009532798-2022-00120
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037301364
• UDI-Public: 03701037301364
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/15/2022

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: 08/01/2022
• Device Model Number: 313-0706
• Device Catalogue Number: 313-0706
• Device Lot Number: L0588
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 08/03/2022
• 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