MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number 300-01-11

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: equinoxe torque defining square drive screw kit 300-20-02; equinoxe replicator plate 4.5mm offset 300-10-45; equinoxe humeral head short 47mm 310-01-47.

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2021.No traumatic event reported.The patient complained of pain & clicking during ambulation of the shoulder.Images indicated that the stem had loosened as a small area of lucency was observed around the stem.The humeral head & torque screw were removed.The stem was observed to be loose & removed from the humeral shaft by pulling on the replicator plate.The glenoid component was observed to be well-fixed & the integrity of the subscapularis was evaluated.The surgeon determined that the atsa construct was still appropriate given the favorable strength of the subscapularis.A 8mm x 175mm revision stem was cemented in the humeral shaft.A new 4.5mm offset replicator plate, torque screw, & humeral head component were implanted.Then, the subscapularis was repaired.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17044468
• MDR Text Key: 316383236
• Report Number: 1038671-2023-01208
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 300-01-11
• Device Catalogue Number: 300-01-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/09/2023
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• 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 Age: 67 YR
• Patient Sex: Male