MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-36-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 03/25/2024

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation: (d10) concomitant device(s): 7075132 - 300-30-06 - equinoxe preserve stem 6mm.A134871 - 320-10-00 - equinoxe reverse tray adapter plate tray +0.A163984 - 320-15-05 - eq rev locking screw.A112927- 320-20-00 - eq reverse torque defining screw kit.S380806 - 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.A172792 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.S377754 - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.A183631 - 320-31-36 - glenosphere, 36mm.A122745 - 320-35-01 - small glenoid plate.A108172 - 320-36-00 - 145-deg pe 36mm hum liner +0.

Event Description

As reported, the 75 year old female patient had an initial right tsa on (b)(6) 2022.The patient was revised on (b)(6) 2024 due to instability.The surgeon removed a small 36 glenosphere and 36 liner.He revised to a small 40+4 glenosphere and 40+2.5 liner.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: matt collins ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19122341
• MDR Text Key: 340339610
• Report Number: 1038671-2024-00877
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-36-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female