MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE L POST AUG, 8 DEG, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 5 years and 8 months post the initial left total shoulder arthroplasty, the patient was revised due to component loosening.There was severe bone loss.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: eq preserve stem 300-30-08 5596558 rs expanded glenosphere 42mm +4 320-02-42 4260421 eq rev adapter plate tray +0 320-10-00 5755634 rs glenoid plate l post aug 8 deg left 320-15-03 5611197 eq rev locking screw 320-15-05 5828167 eq rev torque screw kit 320-20-00 5845484 eq rev compr screw 26mm 320-20-26 5727361 eq rev compr screw 30mm 320-20-30 5696767 eq rev compr screw 38mm 320-20-38 5718211 eq rev 42mm humeral liner +0 320-42-00 5737772.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may be the result of the glenoid and humeral component loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS GLENOID PLATE L POST AUG, 8 DEG, LEFT
• 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
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20948152
• Report Number: 1038671-2024-04869
• Device Sequence Number: 18191557
• Product Code: KWS
• UDI-Device Identifier: 10885862186683
• UDI-Public: 10885862186683
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 320-15-03
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 06/10/2025
• Date Device Manufactured: 09/04/2018
• 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: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male