MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +2.5MM UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 36MM HUMERAL LINER +2.5MM UNCONSTRAINED

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

Patient Problem Bone Fracture(s) (1870)

Event Date 07/28/2023

Event Type  Injury  

Event Description

As reported, approximately one year post initial right tsa, the 63 y/o female patient had a revision due to periprosthetic fracture patient's stem, adapter tray and liner were exchanged.Surgeon used a hrp to rebuild the humerus.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation as they were disposed at the hospital.No other patient information/medical history reported.

Manufacturer Narrative

Section d10: concomitant products: 12.5mm platform fx stem right (cat# 304-22-13 / serial# (b)(6)).Equinoxe reverse tray adapter plate tray +0 (cat# 20-10-00 / serial# (b)(6)).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Manufacturer Narrative

H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: 36MM HUMERAL LINER +2.5MM 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17671576
• MDR Text Key: 322521614
• Report Number: 1038671-2023-02136
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086624
• UDI-Public: 10885862086624
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: 36MM HUMERAL LINER +2.5MM UNCONSTRAINED
• Device Catalogue Number: 320-36-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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: 36MM GLENOSPHERE; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV GLENOID PLATE; EQ REV LOCKING SCREW
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female