MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE REVERSE 46MM HUMERAL LINER +0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 10/16/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial#: (b)(4), equinoxe reverse 46mm glenosphere (cat# 320-01-46 / serial#: (b)(4), eq reverse torque defining screw kit (cat# 320-20-00 / serial#: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the equinoxe shoulder study, approximately five years post initial right side tsa, the 62 y/o male patient was lifting a sign overhead and had sharp pain.Patient experienced disassociation of polyethylene.Patient had a revision approximately a month later and the event was resolved.

Manufacturer Narrative

(h3 the revision reported may have been the result of incomplete seating of the liner during implantation, bone impingement, patient-related conditions, an unreported post traumatic event, or any combination of these possibilities, which led to humeral liner disassociation.However, this cannot be confirmed as the devices were not returned for evaluation and images/radiographs were unable to be obtained.The most probable root cause associated with the reported event of ¿humeral liner disassociation¿ is associated with post-operative disassociation of the humeral liner component from the humeral adapter tray/plate.Do not use for humeral liner seating difficulty.

• Brand Name: EQUINOXE REVERSE 46MM 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15874689
• MDR Text Key: 304426215
• Report Number: 1038671-2022-01522
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: EQUINOXE REVERSE 46MM HUMERAL LINER +0
• Device Catalogue Number: 320-46-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2017
• 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: EQ REV COMPRESS SCREW.; EQ REV COMPRESS SCREW.; EQ REV GLENOID PLATE.; EQ REV LOCKING SCREW.; EQUINOXE PRESERVE STEM 8MM.; EQUINOXE REVERSE SHOULDER DRILL KIT.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White