MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID MEDIUM, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UHMWPE POST AUG GLENOID MEDIUM, RIGHT
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately one year post initial right tsa, the 59 y/o male patient was revised as the initial implant was poorly cemented in.There was no cement in the peg holes to hold the implant in place.All components, except for the humeral stem, were revised.The implants were changed from a shoulder anatomic to a shoulder reverse.A 36mm liner was implanted.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Images received.Sales rep was unable to obtain x-rays.The devices are not available for evaluation due to the devices were disposed at hospital.
Additional Manufacturer Narrative
Section d10: concomitant products.Equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6).Equinoxe replicator plate 1.5mm o/s (cat# 300-10-15 / serial# (b)(6).Equinoxe replicator plate 1.5mm o/s (cat# 300-10-15 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h6 medical device problem code, component code.
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the implant and the bone which led to aseptic (non-infected) loosening of the glenoid component.It was reported that the ¿implant was poorly cemented in.There was no cement in the pegs holes to hold the implant in place.¿ eccentric loading and an excessive cement on the backside of the glenoid likely contributed to the reported loosening.However, this cannot be confirmed because the component was not returned for evaluation.

• Brand Name: UHMWPE POST AUG GLENOID MEDIUM, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, NON-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: kate jacobson
• MDR Report Key: 18331029
• Report Number: 1038671-2023-02981
• Device Sequence Number: 15129234
• Product Code: KWT
• UDI-Device Identifier: 10885862175106
• UDI-Public: 10885862175106
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: UHMWPE POST AUG GLENOID MEDIUM, RIGHT
• Device Catalogue Number: 314-02-33
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 02/19/2024; 11/11/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 05/15/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• 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: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male