MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 5; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	190-30-05
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6), 01-030-01-0450 - alt cup clstr g4 sz 50; (b)(6), 01-030-40-0436 - alt xle lnr ntrl g4 36; (b)(6) 170-36-93 - biolox delta femoral head 36mm od, -3.5mm.
Event or Problem Description
Approximately 12 days after left tha, the patient was revised due to subsidence and a lesser trochanter fracture.The stem and ceramic ball were revised.The patient was revised to exactech devices.The event is not related to the breakage of a device.The event did not cause a surgical delay/prolongation.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d6a, h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the revision reported cannot be confirmed from the information provided but may be the result of the reported femoral stem subsidence and bone fracture.The reported femoral stem subsidence and bone fracture 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
According to the information provided, the female patient underwent a left total hip replacement surgery.Approximately 2 years later, the patient underwent a revision due to hip stem subsidence and bone fracture of the lesser trochanter.Components were not returned to exactech for evaluation and no images, radiographs, and relevant clinical information were provided.

• Brand Name: ALT HA S CLR STD SZ 5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19754951
• Report Number: 1038671-2024-02405
• Device Sequence Number: 12384955
• Product Code: MEH
• UDI-Device Identifier: 10885862321077
• UDI-Public: 10885862321077
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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 Catalogue Number: 190-30-05
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/22/2025
• Date Device Manufactured: 02/13/2023
• 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 H11.
• Patient Age: 70 YR
• Patient Sex: Female