MAUDE Adverse Event Report: EXACTECH, INC. ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	164-01-12
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): novation gxl liner, neutral 28mm, 130-28-51, (b)(6); novation crown cup clstr hole, 180-11-50, (b)(6); ball-head ceramic biolox delta, 179-01-28, (b)(6).
Event or Problem Description
As reported, approximately 7 years post op initial right tha, this female patient was revised due to a periprosthetic hip fracture.Everything was removed.Surgeon cabled the fracture around the stem.The ceramic head and liner were exchanged.He used a ceramic head from zimmer biomet and a 32mm ehxl liner for the crown cup.Patient was last known to be in stable condition following the event.No x-rays available.Device are not returning - disposed at the hospital.
Additional Manufacturer Narrative
Section h10: (g2) report source - company representative should have been checked (g4) date received by manufacturer ¿ date on final submission should have been 16-dec-2023.(g6) type of report - 30-day should have been checked along with follow-up.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for periprosthetic bone fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d8, h2, h3, h6 clinical code, device problem code, investigation findings, investigation conclusion codes.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: ELEMENT-STEM, COLLARLESS W/HA, STD OFFSET, SZ 12
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17549084
• Report Number: 1038671-2023-01947
• Device Sequence Number: 6797236
• Product Code: JDI
• UDI-Device Identifier: 10885862035103
• UDI-Public: 10885862035103
• 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: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/23/2025

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: 12/02/2020
• Device Catalogue Number: 164-01-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023; 01/12/2024; 12/08/2025
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/12/2024; 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2015
• 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 H10.
• Patient Sex: Female