MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS SHOULDER; UNCEMENTED HEMI SHOULDER PROSTHESIS

Catalog Number 313-0706

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2019

Event Type  Injury  

Event Description

A revision surgery occurred approximately two months after the primary surgery ((b)(6) 2019).According to the sales rep, the polyethylene humeral cup spun out.The original polyethylene cup (135/145 36/+6 humeral cup, ref (b)(4)), was replaced with a new polyethylene 36/+6 humeral cup plus a +9mm reversed adapter.

• Brand Name: HUMERIS SHOULDER
• Type of Device: UNCEMENTED HEMI SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: samantha sterling ; 13465 midway rd; suite 101; dallas, TX 75244 ; 2148904109
• MDR Report Key: 8722492
• MDR Text Key: 148791982
• Report Number: 3014128390-2019-00016
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/21/2019

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 Operator: No Information
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 313-0706
• Device Lot Number: M0406
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 06/21/2019
• 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; Required Intervention
• Patient Age: 66 YR