MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL LINER, 40MM, +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-40-03

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 05/17/2023

Event Type  Injury  

Event Description

It was reported that this patient was revised.Reason for the revision is unknown.

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6); 319-01-32 - steinmann pin sterile 3.2mm x 178mm, (b)(6); 320-10-05 - equinoxe reverse tray adapter plate tray +5, (b)(6); 320-15-05 - eq rev locking screw, (b)(6); 320-20-00 - eq reverse torque defining screw kit, (b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6); 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(6); 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6); 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(6); 320-32-40 - expanded glenosphere, 40mm, for small reverse, (b)(6); 320-35-02 - small superior augment glenoid plate, (b)(6); 321-52-07 - 3.2mm drill bit sterile, (b)(6).

• Brand Name: HUMERAL LINER, 40MM, +2.5
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17555650
• MDR Text Key: 321344945
• Report Number: 1038671-2023-01962
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-40-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2021
• 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
• Treatment: SEE H10