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

Catalog Number	300-01-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
H6: corrected the following: investigation findings, investigation conclusions manufacturer narrative updated: the revision reported was likely the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were unable to be obtained.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM
• Common Device Name: 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
• Report Number: 1038671-2024-00789
• Device Sequence Number: 20740342
• Product Code: HSD
• UDI-Device Identifier: 10885862079305
• UDI-Public: 10885862079305
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 300-01-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 05/17/2024; 08/23/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/30/2024; 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female