MAUDE Adverse Event Report: EXACTECH, INC. ALTEON HPS STD SZ 12; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL

Model Number	ALTEON HPS STD SZ 12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 10 months post op the initial hip replacement, this 73 y/o male patient had a loose stem due to a cement fracture.It was reported that the revision of the stem hasn¿t occurred.Photos and x-rays provided.Product not returning as it remains implanted at this time.
Additional Manufacturer Narrative
Outcomes attributed to adverse event: future revision indicated.Device remains implanted at this time.
Additional Manufacturer Narrative
H6: the revision reported may have been the result of failure of the cement used to secure the femoral stem to the femoral bone, possibly due to handling properties, mechanical properties, structure, and composition, which led to cement mantle fraction and femoral stem loosening.However, this cannot be confirmed as there were no details regarding cement used, cementing techniques, or operative conditions provided and the devices were not returned for evaluation.
Event or Problem Description
The rep believes the revision of the exactech hps stem has occurred and the patient was revised to a competitor's prosthesis.Revision date unknown.On the initial surgery on (b)(6) 2023 the surgeon utilized a competitors actebaular components because he wanted a dual mobility construct.

• Brand Name: ALTEON HPS STD SZ 12
• Common Device Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14879904
• Report Number: 1038671-2022-00748
• Device Sequence Number: 5163271
• Product Code: KWL
• UDI-Device Identifier: 10885862526977
• UDI-Public: 10885862526977
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ALTEON HPS STD SZ 12
• Device Catalogue Number: 190-60-12
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male