MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 2

Model Number 300-62-02

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

Patient Problem Failure of Implant (1924)

Event Date 09/23/2021

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant device(s): 310-62-44, 6143501 - stemless humeral head 44 x 14 beta.

Event Description

As reported, approximately 2 yrs postop the initial ltsa, this 55 y/o female patient underwent a hemi that was converted to reverse due to pain with a hemi and subscap failure.Patient was last known to be in stable condition following the event and devices will not return due to facility policy.

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 pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: STEMLESS HUMERAL COMP INTEGRIP, CAGE, SIZE 2
• 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: 12646302
• MDR Text Key: 276850932
• Report Number: 1038671-2021-00540
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862536754
• UDI-Public: 10885862536754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173388
• 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: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-62-02
• Device Catalogue Number: 300-62-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female