MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S NOCLR EXT SZ 9; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	190-21-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a 54 yo female patient, who had a left hip implanted, underwent a revision procedure.The patient was revised due to the stem was loose and needed to be revised.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted device is not available for return due to hospital policy.A device image was provided.No further information.
Additional Manufacturer Narrative
D10: (b)(6) 01-030-01-0450 - alt cup clstr g4 sz 50.(b)(6) 01-030-40-0432 - alt xle lnr ntrl g4 32.(b)(6) 170-32-00 - biolox delta femoral head 32mm od, +0mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, 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 femoral stem loosening.The reported femoral stem loosening could not be confirmed from the image provided.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs 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 9
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22723522
• Report Number: 1038671-2025-02689
• Device Sequence Number: 8989913
• Product Code: MEH
• UDI-Device Identifier: 10885862321244
• UDI-Public: 10885862321244
• 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: 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): 08/21/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2024
• Device Catalogue Number: 190-21-09
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2019
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female