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

Catalog Number	320-15-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10.Cocomitants: 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.320-42-03 - equinoxe reverse 42mm humeral liner +2.5.320-10-00 - equinoxe reverse tray adapter plate tray +0.320-01-42 - equinoxe reverse 42mm glenosphere.
Event or Problem Description
It was reported via clinical study that the 66 yo female patient experienced aseptic glenoid loosening and gradual baseplate loosening with broken screw.No specific mechanism was noted.The date of onset is (b)(6) 2022.The patient was revised on (b)(6) 2022.The outcome was last known as resolved.
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the left side; followed by a shoulder revision due to aseptic glenoid loosening with osteolysis in hybrid tsa, approximately 2.5 years post-operatively.Subsequently, the patient has experienced aseptic glenoid loosening and gradual baseplate loosening with broken screw.No specific mechanism was noted.Pain was also reported.As a result, approximately 3 years after first revision, the patient underwent a second left shoulder revision procedure.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: d10, g1, h6.The following sections were corrected: b5, d6b, h6 - clinical, impact codes.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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of glenoid loosening and screw fracture.The reported glenoid loosening and fracture could not be confirmed.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.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, L 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, INC.; 2320 nw 66th ct.; FL 32563
• Manufacturer Contact: geoff gannon
• MDR Report Key: 17452205
• Report Number: 1038671-2023-01123
• Device Sequence Number: 15271435
• Product Code: KWS
• UDI-Device Identifier: 10885862242556
• UDI-Public: 10885862242556
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2025

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 Catalogue Number: 320-15-07
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 03/27/2025; 04/11/2025
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 04/01/2025; 04/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2019
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White