MAUDE Adverse Event Report: CARTIHEAL LTD. IMPLANT 2 PACK ARAGONITE D7.5 H10; IMPLANT, RESORBABLE, FOR ARTICULAR OSTEOCHONDRAL REPAIR

Catalog Number	CHP0752
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Arthralgia (2355); Cartilage damage (4833)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, after an initial surgery that included a cartilage repair with three (3) agili-c implants, an acl reconstruction with a quad autograft, a meniscal repair, and an let (lateral extra-articular tenodesis) had been performed on (b)(6) 2025, in which the patient was implanted with two (2) agili-c plugs to the lateral femoral condyle and one (1) to the trochlea, the patient experienced continued pain on an unspecified date.This adverse event was addressed on (b)(6) 2025 by revising the two (2) agili-c implants in the lateral femoral condyle, using osteochondral allograft.The surgeon noticed that there was very little cartilage growth over the area.Currently, the patient is doing well and recovering from their surgery.
Additional Manufacturer Narrative
H11: h2: corrected information on: h6 (clinical code and medical device problem code).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that further patient details and post-op instructions/restrictions are unknown.The provided photos appear to show a thinning articular cartilage lesion with possibly less than the minimum 5mm bone-bridge between the condyle implants, and a possible distal condyle scaffold implant protrusion; however, this may be due to inadequate visualization in the images.Comparison photos and dates of the implant-photo is unknown.The ifu warns against use in in the setting of ligamentous instability and obesity, to avoid extreme forces during the recuperation, and that non-press fit positioning may lead to failure due to lack of implant integration.Failure to induce tissue regeneration/lack of new tissue formation or cartilage integration/partial ingrowth in included in the adverse reactions.It includes appropriate implantation techniques.The patient¿s preexisting comorbidities, immediate post-implantation outcome, and post-op instructions/restrictions are unknown.Additionally, it cannot be determined with certainty if the multiple surgical procedures may have impacted implant success/surgical outcome.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the limited information provided a thorough medical assessment could not be performed; therefore, we are unable to conclude specific factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: IMPLANT 2 PACK ARAGONITE D7.5 H10
• Common Device Name: IMPLANT, RESORBABLE, FOR ARTICULAR OSTEOCHONDRAL REPAIR
• Manufacturer (Section D): CARTIHEAL LTD.; 17 atir yeda street; kfar saba central IL 44643 13; IS 4464313
• Manufacturer (Section G): CARTIHEAL LTD.; 17 atir yeda street; kfar saba central IL 44643 13; IS 4464313
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 24073226
• Report Number: 3013881076-2026-00001
• Device Sequence Number: 9130389
• Product Code: QRU
• UDI-Device Identifier: 07290019087168
• UDI-Public: 7290019087168
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P210034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/10/2026

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: CHP0752
• Device Lot Number: 161
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2024
• 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: PN: CH-075, LN: 154, SN: (B)(6)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female