MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number SHOULDER IMPLANT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

As reported by the equinoxe shoulder study, approximately one year post initial tsa, the 69 y/o male patient had broken screw identified on x-ray.The event was resolved.Patient is doing well.Patient is asymptomatic.No action taken.Per clinical report, the reported event is definitely not related to the device and unlikely related to the procedure.

Manufacturer Narrative

Section d10: concomitant products; reverse humeral liner (cat# 320-42-00 / serial# (b)(6), reverse humeral tray (cat# 320-10-00 / serial# (b)(6), reverse glenosphere baseplate (cat# 320-15-06 / serial# (b)(6), equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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: 17721832
• MDR Text Key: 323103451
• Report Number: 1038671-2023-02232
• Device Sequence Number: 1
• Product Code: KWT
• 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
• Report Date: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHOULDER IMPLANT
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White