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

Model Number ALTEON HPS STD SZ 12

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

Patient Problem Failure of Implant (1924)

Event Date 06/05/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

Outcomes attributed to adverse event: future revision indicated.Device remains implanted at this time.

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 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
• Type of Device: 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
• MDR Text Key: 302700009
• Report Number: 1038671-2022-00748
• Device Sequence Number: 1
• Product Code: KWL
• UDI-Device Identifier: 10885862526977
• UDI-Public: 10885862526977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male