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

Catalog Number	300-01-11
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Implant Pain (4561); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient who had an initial right shoulder implanted in march of 2020, underwent a revision procedure approximately 3 years 7 months post the initial procedure.The patient had presented to the surgeon with a sore shoulder.During the revision procedure, the stem was found to be loosening.The surgeon removed the humeral stem and replaced it with a cemented stem.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted device is not available for analysis as it was discarded by the customer.Device images were provided.
Additional Manufacturer Narrative
D10: concomitants: 5637620 321-20-00 - equinoxe reverse shoulder drill kit 6467533 320-42-00 - equinoxe reverse 42mm humeral liner +0 6480456 315-35-00 - glnd kwire 6481332 315-35-00 - glnd kwire 6498150 320-15-01 - eq rev glenoid plate 6541859 320-15-05 - eq rev locking screw 6578164 320-10-00 - equinoxe reverse tray adapter plate tray +0 6627567 320-01-42 - equinoxe reverse 42mm glenosphere 6648322 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm 6689010 320-20-00 - eq reverse torque defining screw kit s079249 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm s082314 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm s083976 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.
Additional Manufacturer Narrative
Correction h6: health effect-clinical code.Additional information: h3: 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 radiographs were not provided.H6: component code, investigation codes.

• Brand Name: EQUINOXE
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 19588166
• Report Number: 1038671-2024-02065
• Device Sequence Number: 7195306
• Product Code: HSD
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• 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: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: 300-01-11
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2020
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male