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

Catalog Number 103-0007

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was revised on due to infection and instability, approximately 6 months after the first surgery.The date of the revision is unknown.The surgeon explanted 1 humeral cup 36+3 and 1 spacer +9.The surgeon implanted 1 humeral cup 36+3 and 1 spacer +9.

• Brand Name: HUMELOCK 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: 15389211
• MDR Text Key: 299552509
• Report Number: 3009532798-2022-00126
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00370103730008
• UDI-Public: 0370103730008
• 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: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 103-0007
• Device Lot Number: P0262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization