MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; SEE H10

Model Number ALT HA S NOCLR STD SZ 5

Device Problem Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 01/15/2023

Event Type  Injury  

Manufacturer Narrative

Procode: prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate.Concomitant medical products: 7258908, 01-030-01-0756 - alt cup clstr g7 sz 56; 7184920, 01-030-40-0736 - alt xle lnr ntrl g7 36; 7194400, 170-36-03 - biolox delta femoral head 36mm od, +3.5mm; 7125592, 190-20-05 - alt ha s noclr std sz 5; additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported a 60 yo male patient, initial right hip implanted on (b)(6) 2022, underwent a revision procedure on (b)(6) 2023, approximately 5 months post the initial procedure.The stem subsided sometime after the initial surgery and had to be revised.The original stem and head were removed and replaced with larger sizes.The patient was last known to be in stable condition following the event.No product returning as the patient wanted it.No further information.

• Brand Name: ALTEON
• Type of Device: SEE H10
• 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: 16465025
• MDR Text Key: 310488820
• Report Number: 1038671-2023-00327
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 10885862321824
• UDI-Public: 10885862321824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162732
• 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
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALT HA S NOCLR STD SZ 5
• Device Catalogue Number: 190-20-05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Date Device Manufactured: 10/04/2021
• 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 Age: 60 YR
• Patient Sex: Male