MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number 300-01-09

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

Patient Problem Failure of Implant (1924)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Pending investigation.4697961 320-15-05 - eq rev locking screw 4700324 320-38-03 - equinoxe reverse 38mm humeral liner +2.5 4980155 320-15-04 - rs glenoid plate post aug, 8 deg, right 4994096 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm 5033192 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm 5036261 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm 5093116 320-10-00 - equinoxe reverse tray adapter plate tray +0 5116438 320-20-00 - eq reverse torque defining screw kit.

Event Description

It was reported that a 82 yo female patient, initial right shoulder implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2024, approximately 6 years 3 months post the initial procedure.The revision was performed due to aseptic loosening of the humeral stem.The glenosphere was exchanged for an exactech device.The stem was removed and replaced by a competitor¿s product.There was no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No device returns for analysis anticipated as they were discarded by the hospital.No x-rays or device images were able to be obtained.No further information.

Manufacturer Narrative

H3: the geosphere, liner and adapter tray were appropriately released for distribution.The reason for the patient's infection and subsequent revision procedure as related to the devices cannot be conclusively determined.There was no medical or clinical information provided.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• 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: matt collins ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19084714
• MDR Text Key: 339877456
• Report Number: 1038671-2024-00789
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• 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
• Report Date: 05/30/2024

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 Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female