MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL LINER +0

Model Number 320-42-00

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant device(s): 300-30-12, equinoxe preserve stem 12mm, 320-10-00, equinoxe reverse tray adapter plate tray +0, 320-02-42, rs expanded glenosphere 42mm, +4mm offset, 320-15-01, eq rev glenoid plate.

Event Description

As reported, approximately 3 years post op left tsa, this (b)(6) male patient was revised due to swelling.Swelling started without inquiry around (b)(6) 2021.Previously placed rotator cuff anchor migrated.The case report form indicates this event is definitely not related to devices or procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Section h10: (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 the migrating anchor/swelling cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: *the following sections have corrected information: (b5) as reported by equinoxe shoulder study, approximately 3 years post op left reverse tsa for rotator cuff arthropathy, this (b)(6).Y/o male patient developed swelling in his left shoulder around (b)(6).2021 without injury.Related to migration of anchor or screw.No additional information.

Event Description

As reported by equinoxe shoulder study, approximately 3 years post op left reverse tsa for rotator cuff arthropathy, this 82 y/o male patient developed swelling in his left shoulder around (b)(6).2021 without injury.Related to migration of anchor or screw.No additional information.

• Brand Name: EQUINOXE
• Type of Device: REVERSE 42MM HUMERAL LINER +0
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 13522709
• MDR Text Key: 285532584
• Report Number: 1038671-2022-00195
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086693
• UDI-Public: 10885862086693
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-42-00
• Device Catalogue Number: 320-42-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White