MAUDE Adverse Event Report: EXACTECH, INC. ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 9; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 9
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10.5 years post initial tha, the male patient had a revision due to per-prosthetic fracture.There was no breakage of device or surgical delay/prolongation.Surgeon removed all implants.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays and images.The device is not available for evaluation as it was disposed at the hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
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 information.The following sections were updated: h3, h6, h11.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.A review of complaint history determined that no further action is required as no trends were identified.The reason for the revision reported was likely due to a periprosthetic bone fracture.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition, a traumatic event, and/or surgical techniques.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 9
• 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: geoff gannon ; 3525541928
• MDR Report Key: 17671670
• Report Number: 1038671-2023-02137
• Device Sequence Number: 6434589
• Product Code: KWT
• UDI-Device Identifier: 10885862035073
• UDI-Public: 10885862035073
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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 Expiration Date: 03/18/2017
• Device Model Number: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 9
• Device Catalogue Number: 164-01-09
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male