MAUDE Adverse Event Report: EXACTECH, INC. ALT HA S NOCLR EXT SZ 6; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	190-21-06
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6) 01-030-01-0552 - alt cup clstr g5 sz 52.(b)(6) 01-030-40-0532 - alt xle lnr ntrl g5 32.(b)(6) 170-32-93 - biolox delta femoral head 32mm od, -3.5mm.(b)(6) 180-65-30 - alteon 6.5mm screw, 30mm.Unassigned, 32135-38h-17 - 17-4 flex drill m 3.2x38 lenkbar.
Event or Problem Description
It was reported that this 78 y/o female patient's right hip was revised approximately 1 year 4 months post op.Patient's alteon ha stem was grossly loose.The surgeon was able to remove the stem by hand.Patient was last known to be in stable condition following the event.Unable to obtain images or x-rays.Ebi attached.Product not returning: hospital policy.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely the result of femoral stem loosening.However this cannot be confirmed and 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, 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 6
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20233280
• Report Number: 1038671-2024-03548
• Device Sequence Number: 8042916
• Product Code: MEH
• UDI-Device Identifier: 10885862321213
• UDI-Public: 10885862321213
• 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: 2023
• 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): 02/13/2025

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 Catalogue Number: 190-21-06
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 12/19/2016
• 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: 78 YR
• Patient Sex: Female