MAUDE Adverse Event Report: Exactech, Inc. ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 14; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu

Catalog Number	164-01-14
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Report #2 of 2 for this event.As reported via legal documentation this patient had a right total hip arthroplasty.Subsequently, five (5) years, four (4) months later the patient underwent a revision procedure due to prosthesis wear.A revision operative report was provided.Intraoperatively, the femoral stem was determined to be loose.The patient tolerated the procedure well.No further information is available.

• Brand Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 14
• Common Device Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu
• Manufacturer (Section D): Exactech, Inc.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): Exactech,Inc.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 50532344
• Report Number: 1038671-2026-01110
• Device Sequence Number: 5963417
• Product Code: MEH
• UDI-Device Identifier: 10885862035127
• UDI-Public: 10885862035127
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 12/02/2018
• Device Catalogue Number: 164-01-14
• 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: 10/10/2023
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 12/05/2013
• 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: Hospitalization; Required Intervention
• Patient Sex: Male