MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-01-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, who had an initial right shoulder implanted in (b)(6) of 2019, underwent a revision procedure approximately 5 years 4 months post the initial procedure due to periprosthetic fracture.The patient was revised to an equinoxe reverse.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for analysis as they were disposed by the customer.No device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 4319701 300-10-15 - equinoxe replicator plate 1.5mm o/s 4162786 300-20-02 - equinox square torque define screw drive kit 3616644 310-02-47 - equinoxe, humeral head tall, 47mm (beta) 3795623 314-02-34 - uhmwpe post aug glenoid large, right 5660547 315-35-00 - glnd kwire 5441957 531-20-00 - shldr gps rvrs drill kit 5504085 531-78-20 - shouldr gps hex pins kit 08013018182 a10012 - gps implant kit v2.
Event or Problem Description
Humeral bone fracture.
Additional Manufacturer Narrative
Additional information b5 h3: the reason for the revision reported was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.H6: component code, investigation codes.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 19629141
• Report Number: 1038671-2024-02185
• Device Sequence Number: 7092927
• Product Code: KWS
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• 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: 2019
• 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): 10/18/2024

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: 300-01-13
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2018
• 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: 67 YR
• Patient Sex: Male