MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; UNCIMENTED SHOULDER PROTHESIS

Catalog Number 312-3612

Device Problem Entrapment of Device (1212)

Patient Problems Bacterial Infection (1735); Fistula (1862); Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2022

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in france) and was associated with a product that also cleared for the market within the united stated.

Event Description

The patient was revised on (b)(6) 2017 due to infection, approximately 1743 days after the first surgery.The surgeon explanted 1 stem, 1 cup, 1 glenosphere, 2 locking screw and 2 screws.The surgeon implanted 1 stem, 1 cup, 1 glenosphere, 1 cortical screw, 1 locking screw.Infection with the propionibacterium acnes germ.Presence of a fistula in the axilla.Change of humeral stem, humeral cup, glenosphere and two locking screws.The standard screws have been lifted but not changed.The metaglene could not be removed because it was very osteointegrated.

• Brand Name: HUMELOCK REVERSED
• Type of Device: UNCIMENTED 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: 15155523
• MDR Text Key: 297139944
• Report Number: 3009532798-2022-00122
• Device Sequence Number: 1
• Product Code: HSD
• 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

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 312-3612
• Device Lot Number: L1834
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2022
• 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