MAUDE Adverse Event Report: EXACTECH, INC. SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 6 year(s), 3 month(s) and 27 day(s) post-operative of a right tsa, the patient presented with disassociation of polyethylene.Subject presented with extruded poly from tray after using heavy hedger; during surgery it was noted that baseplate was also loose.The patient underwent standard reverse with preserve stem revision surgery and the outcome is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-12 - equinoxe preserve stem 12mm: 5151395.315-35-00 - glnd kwire: 5191953.320-01-42 - equinoxe reverse 42mm glenosphere: 5178049.320-15-05 - eq rev locking screw: 4953908.320-20-00 - eq reverse torque defining screw kit: 5182471.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 5124051.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 5124053.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 5124397.531-20-00 - shldr gps rvrs drill kit: 5007839.A10012 - gps implant kit v2: 10000017186.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d4, h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported may have been due to disassembly of the humeral liner from the humeral head, and/or loosening of the glenoid baseplate.However, the reported disassembly and glenoid loosening could not be confirmed.Potential contributions of manufacturing, user, and patient-related considerations, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported event cannot be determined, as the devices were not available for evaluation and images, radiographs, relevant clinical information, and product information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19776430
• Report Number: 1038671-2024-02444
• Device Sequence Number: 18190117
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-08
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 03/15/2017
• 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 H11
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Race: White