MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA); PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 310-02-44

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

Patient Problem Loss of Range of Motion (2032)

Event Date 05/25/2023

Event Type  Injury  

Event Description

As reported, approximately 1 years post op initial right tsa, this 73 y/o female patient was revised.Patient has complained of tightness and impingement, so decision was made to reduce implant height to address problem.A short humeral head was implanted.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain photos/x-rays.Product not returning - disposed at hospital.

Manufacturer Narrative

Section h10: (h3) pending evaluation, (d10) concomitant device(s): 7065631 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.7154164 300-21-00 - 0mm fixed angled kit.6448677 314-13-02 - equinoxe cage glenoid small, alpha.6893147 315-35-00 - glnd kwire.7095274 321-52-09 - 3.2mm k-wire, trocar tip.7136857 531-20-00 - shldr gps rvrs drill kit.A005959 531-78-20 - shoulder gps hex pins kit.11018221129 a10012 - gps implant kit v2.

Manufacturer Narrative

Section h10: (h3) the cause of the patient¿s tightness and impingement with subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.It appears that the initial selection of implant size affected the patient, as the revision provided a short humeral head to address implant height.These devices are used for treatment not diagnosis.

Manufacturer Narrative

Section h10: (g2) report source - company representative should have been checked.(g4) date received by manufacturer ¿ date on final submission should have been 16-dec-2023.(g6) type of report - 30-day should have been checked along with follow-up.

• Brand Name: EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA)
• 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: 17342999
• MDR Text Key: 319279174
• Report Number: 1038671-2023-01694
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862083937
• UDI-Public: 10885862083937
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042021
• 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,Followup,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 310-02-44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2019
• 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 Age: 73 YR
• Patient Sex: Female