MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S NOCLR STD SZ 5; SEE H10

Model Number	ALT HA S NOCLR STD SZ 5
Medical Device Problem Codes	Positioning Failure (1158); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d6b, h6.Explant date is unknown.The reason for the revision reported cannot be confirmed from the information provided but may be the result of the reported femoral stem subsidence.The reported femoral stem subsidence could not be confirmed from the information provided as images and radiographs were not provided.The explanted devices were not available for evaluation and relevant clinical notes were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a male patient, had an initial right hip implanted and underwent a revision procedure.Approximately five 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: ALT HA S NOCLR STD SZ 5
• Common Device Name: 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
• Report Number: 1038671-2023-00327
• Device Sequence Number: 5063916
• Product Code: MEH
• UDI-Device Identifier: 10885862321824
• UDI-Public: 10885862321824
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 10/03/2026
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 10/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male