MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 10MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-30-10

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/23/2022

Event Type  Injury  

Manufacturer Narrative

(h3) pending evaluation (d10) concomitant device(s): (b)(6) : 300-10-15 - equinoxe replicator plate 1.5mm o/s.(b)(6): 310-01-44 - equinoxe, humeral head short, 44mm (alpha).(b)(6): 314-13-02 - equinoxe cage glenoid small, alpha.(b)(6): 300-20-02 - equinox square torque define screw drive kit.

Event Description

As reported by the equinoxe shoulder study, the 73 year old female patient had an initial left tsa on (b)(6) 2018 and presented with humeral fracture, 4 year(s) and 4 month(s) post initial procedure on (b)(6) 2022.Patient slipped and fell onto left shoulder.Additional information: periprosthetic fracture at mid-portion of preserve humeral stem.The case report form indicates that this event is definitely related to the device and definitely not related to the procedure.The report also indicates that the action taken on (b)(6) 2023 was sling, no arom, and relative rest.The outcome is reported as resolved on (b)(6) 2023.Due to clinical study, no devices will be returned for evaluation.1038671-2024-00153 : 300-30-10 - equinoxe preserve stem 10mm.

Manufacturer Narrative

This case previously reported in error.As there is no written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution, this event is not considered a complaint.The patient slipped and fell onto left shoulder.

• Brand Name: EQUINOXE PRESERVE STEM 10MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18645768
• MDR Text Key: 334612063
• Report Number: 1038671-2024-00153
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162726
• 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,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-30-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White