MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S CLR STD SZ 7; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	190-30-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 101-45-30 - 4.5mm drill bit 30mm.(b)(6) - 01-030-40-0536 - alt xle lnr ntrl g5 36.(b)(6) - 170-36-07 - biolox delta femoral head 36mm od, +7mm.(b)(6) - 01-030-01-0552 - alt cup clstr g5 sz 52.(b)(6) - 180-65-35 - alteon 6.5mm screw, 35mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01546.The reason for the revision reported cannot be confirmed from the information provided but may be the result of acetabular loosening and femoral stem loosening.The reported acetabular loosening and femoral stem loosening could not be confirmed.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.
Event or Problem Description
It was reported that approximately 14 months after a left total hip replacement procedure, the patient underwent a revision procedure to address loosening.No further issues or complications were reported.Images were provided.No additional information is available.

• Brand Name: ALT HA S CLR STD SZ 7
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21364954
• Report Number: 1038671-2025-00859
• Device Sequence Number: 12874709
• Product Code: JDI
• UDI-Device Identifier: 10885862321091
• UDI-Public: 10885862321091
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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: 10/03/2026
• Device Catalogue Number: 190-30-07
• 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: 06/14/2023
• Initial Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 10/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female