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

Catalog Number	314-02-33
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant devices: 312-01-47 - resurfacing humeral head 47mm 4160068 312-01-01 - resurfacing cage, 25mm 4781745 h3: customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that this patient's right shoulder was revised.The patient had a humeral resurfacing and over time the glenoid component failed.The surgeon carried out a 1st stage revision with the intent to do a 2nd stage inserting an exactech reverse shoulder.The patient has a cement spacer insitu and is awaiting a 2nd stage revision.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h3: the revision reported was likely due to prothesis wear, loosening, and subsequent migration.The cause of the wear, loosening and migration cannot be confirmed but may be due to underlying rotator cuff deficiencies leading to superior migration of the humeral head, the humeral bone impinging on the implant creating a rocking horse motion around a well-fixed cage, surgical tool damage, and/or the inclusion of the polyethylene in the packaging recall.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.

• Brand Name: UHMWPE POST AUG GLENOID MEDIUM, RIGHT
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21138025
• Report Number: 1038671-2025-00204
• Device Sequence Number: 17844223
• Product Code: KWS
• UDI-Device Identifier: 10885862175106
• UDI-Public: 10885862175106
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 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: 12/16/2024
• Supplement Date Received by Manufacturer: 04/02/2025; 04/28/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 04/21/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Female