MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S NOCLR EXT SZ 12; SEE H10

Model Number	ALT HA S NOCLR EXT SZ 12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient, initial left hip implanted on (b)(6) 2021, underwent a revision procedure on (b)(6) 2024, approximately 2 years 11 months post the initial procedure.A loose stem had to be revised.The stem was reported as grossly loose.The stem was removed and converted to a competitor¿s devices.There were no surgical delays or device breakages during the event.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted devices are not available for analysis due to hospital policy.Device images were provided.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate.D10: concomitants: 6298042 - 01-030-01-0758 - alt cup clstr g7 sz 58.5942937 - 01-030-40-0736 - alt xle lnr ntrl g7 36.6672499 - 170-36-00 - biolox delta femoral head 36mm od, +0mm.S052696 - 180-65-30 - alteon 6.5mm screw, 30mm.4915927 - 190-21-12 - alt ha s noclr ext sz 12.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The following sections were updated/corrected: d1, d4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely the result of femoral stem loosening.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: ALT HA S NOCLR EXT SZ 12
• 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: miguel sosa ; 2320 nw 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18927288
• Report Number: 1038671-2024-00541
• Device Sequence Number: 9364556
• Product Code: MEH
• UDI-Device Identifier: 10885862321275
• UDI-Public: 10885862321275
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K162732
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 08/22/2025

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: 05/31/2022
• Device Model Number: ALT HA S NOCLR EXT SZ 12
• Device Catalogue Number: 190-21-12
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 08/22/2025
• Date Device Manufactured: 06/02/2017
• 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 Sex: Male