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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/11/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 9
• Type of Device: 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 ; 3523771140
• MDR Report Key: 17671670
• MDR Text Key: 322522555
• Report Number: 1038671-2023-02137
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862035073
• UDI-Public: 10885862035073
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/19/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male