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

Catalog Number 106-4800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 for unknown cause, approximately 5 months following primary surgery on (b)(6) 2021.Surgeon explanted +0mm double taper and 48x19 offset cocr head, and then implanted a new +0mm double taper and 50x20 offset cocr head.Additional details are unavailable.

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

• Brand Name: HUMERIS CEMENTLESS ANATOMIC
• Type of Device: METALLIC UNCEMENTED PROSTHESIS SHOULDER
• 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: 12826082
• MDR Text Key: 280870319
• Report Number: 3009532798-2021-00167
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 106-4800
• Device Lot Number: P0455
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• 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