MAUDE Adverse Event Report: EXACTECH, INC. XL, LEFT, 16 POST AUG UHMWPE GLENOID; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-06-25
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately ten years post initial left tsa, the 73 y/o male patient experienced aseptic glenoid loosening.The patient complaining of increasing shoulder pain especially with overhead activities.Aseptic glenoid component loosening.Patient is scheduled a computed tomography (ct) and the event still ongoing.Per clinical report, the reported event is possibly related to the device and unlikely related to procedure.
Additional Manufacturer Narrative
Pending investigation.D10: equinoxe, humeral stem primary, press fit 15mm (cat #: 300-01-15/serial #: (b)(6).Equinoxe replicator plate 4.5mm o/s (cat #: 300-10-45/serial #: (b)(6).Equinox square torque define screw drive kit (cat #: 300-20-02/serial #: (b)(6).Equinoxe, humeral head expanded, 50mm (beta) (cat #: 310-03-50/serial #: (b)(6).Equinoxe reverse shoulder drill kit (cat #: 321-20-00/serial #: (b)(6).
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: XL, LEFT, 16 POST AUG UHMWPE GLENOID
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19341371
• Report Number: 1038671-2024-01307
• Device Sequence Number: 12545407
• Product Code: KWS
• UDI-Device Identifier: 10885862228338
• UDI-Public: 10885862228338
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K121220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2018
• Device Catalogue Number: 314-06-25
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 02/21/2025
• Date Device Manufactured: 03/01/2013
• 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.
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White