MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +2.5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 320-46-03

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 09/12/2022

Event Type  Injury  

Event Description

It was reported that this male patient presented with a left exactech reverse shoulder with a dissociated humeral poly component.Patient did not report any traumatic event.Dissociated poly was removed along with the adapter tray, glenosphere, and locking screws for each.A lateralized glenosphere was implanted as well as a +5 tray and +0 liner.No adverse event as a result.Patient was last known to be in stable condition following the event.

Manufacturer Narrative

Pending evaluation.

• Brand Name: EQUINOXE REVERSE 46MM HUMERAL LINER +2.5
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15536718
• MDR Text Key: 301108943
• Report Number: 1038671-2022-01231
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 320-46-03
• Device Catalogue Number: 320-46-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male
• Patient Weight: 79 KG