MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 38MM HUMERAL LINER +0

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

Patient Problem Osteolysis (2377)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products humeral stem, 15mm (cat# 300-01-15 / serial# (b)(6).Glenosphere, 38mm (cat# 320-01-38 / serial# (b)(6).Humeral adapter tray, +0 (cat# 320-10-00 / serial# (b)(6)).Glenoid plate (cat# 320-15-01 / serial# (b)(6)).Glenosphere locking screw (cat# 320-15-05 / serial# (b)(6).Torque defining screw kit (cat# 320-20-00 / serial# (b)(6)).Compression screw, 4.5 x 22mm, black (cat# 320-20-22 / serial# (b)(6)).Compression screw, 4.5 x 26mm, orange (cat# 320-20-26 / serial# (b)(6)).Compression screw, 4.5 x 30mm, blue (cat# 320-20-30 / serial# (b)(6)).Compression screw, 4.5 x 30mm, blue (cat# 320-20-30 / serial# (b)(6)).Compression screw, 4.5 x 34mm, red (cat# 320-20-34 / serial# (b)(6)).Compression screw, 4.5 x 22mm, black (cat# 320-20-22 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, 6.5 years post initial right tsa, the 80 y/o male patient experienced a large lytic lesion found behind baseplate.All components removed.Void grafted with milled bone.Lima hemi re-implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Photos/x-rays received.The devices are not available for evaluation due to devices were sent to rph for analysis.

Manufacturer Narrative

After further review of additional information received the following sections g1, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of patient conditions, which may have contributed to the osteolysis reported.Upon review of the available information, there is no evidence that this event is a device-related malfunction and there is no allegation against any of the components.The probable root cause for the reported event of ¿osteolysis¿ is associated with destruction or disappearance of bone tissue likely related to weakened integration of an implant at the bone-implant interface.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• 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: matt collins
• MDR Report Key: 18145397
• MDR Text Key: 328224882
• Report Number: 1038671-2023-02799
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• 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: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2021
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL LINER +0
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2016
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male