BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT 2 PACK ARAGONITE D7.5 H10

    MDR report key: 24073226 · Received January 14, 2026

    Report

    Report Number
    3013881076-2026-00001
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 10, 2026
    Manufacturer
    CARTIHEAL LTD.
    Product Code
    QRU
    UDI-DI
    07290019087168
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135582 IMPLANT 2 PACK ARAGONITE D7.5 H10 IMPLANT, RESORBABLE, FOR ARTICULAR OSTEOCHONDRAL REPAIR QRU CARTIHEAL LTD. 161 07290019087168

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization| R PN: CH-075, LN: 154, SN: (B)(6)