BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT 3 PACK ARAGONITE D7.5 H10

    MDR report key: 24079824 · Received January 15, 2026

    Report

    Report Number
    3013881076-2026-00002
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    July 30, 2025
    Report Date
    March 18, 2026
    Manufacturer
    CARTIHEAL LTD.
    Product Code
    QRU
    UDI-DI
    07290019087175
    PMA / PMN Number
    P210034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: H3, H6: THE REPORTED DEVICE WAS NOT AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. A REVIEW OF PRODUCTION RECORDS SHOWED THAT THERE IS NO INDICATION TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOR THE LAST 12 MONTHS REVEALED NO SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY; THERE ARE NO INDICATIONS TO SUGGEST THAT THE ANTICIPATED RISK IS NOT ADEQUATE. A REVIEW OF THE MANUFACTURING PROCESS FOUND THAT DURING THE SHAPING PROCESS THE DEVICE IS 100% INSPECTED TO DETECT VOIDS, OVERLAPPING CHANNELS, CRACKS AND SPOTS, WHICH ARE CONSIDERED NOT ACCEPTABLE. ACCORDING TO THE SURGICAL TECHNIQUE, THE IMPLANT MUST BE (I) PUSHED GENTLY DURING IMPLANTATION, (II) VISUALLY INSPECTED POST-IMPLANTATION TO ENSURE THAT IT WAS NOT FRACTURED, AND (III) RECESSED AT LEAST 2 MM BELOW THE ARTICULAR SURFACE TO ENSURE PROPER IMPLANTATION. CONSIDERING THAT THE IMPLANT WAS LEFT PROUD, THE MOST PROBABLE ROOT CAUSE WAS A FAILURE TO FOLLOW INSTRUCTIONS IN THE SURGICAL TECHNIQUE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN RISKS WITH THE DEVICE ITSELF OR WITH ITS USE 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 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 A CARTILAGE REPAIR SURGERY HAD BEEN CONDUCTED ON (B)(6) 2025 WITH THREE (3) 7.5 MM X 10 MM AGILI-C IMPLANTS ON AN UNSPECIFIED ANATOMICAL LOCATION, THE PATIENT STARTED EXPERIENCING PAIN AND SWELLING AROUND FOUR (4) MONTHS POST-OPERATIVELY. THE SURGEON NOTICED THAT THE MOST POSTERIOR IMPLANT WAS LEFT PROUD. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2025 TO REPLACE SUCH IMPLANT WITH A 10 MM X 10 MM AGILI-C IMPLANT. PART OF THE IMPLANT HAD BROKEN OFF AND WAS FLOATING AROUND IN THE JOINT; IT WAS REMOVED WITH AN ARTHROSCOPIC GRASPER. THE SITE OF THE REVISION WAS PREPARED WITH NORMAL AGILI-C TECHNIQUE FOR A 10MM IMPLANT. THE PATIENT HAS PRESENTED POSITIVE IMPROVEMENTS THUS FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170773 IMPLANT 3 PACK ARAGONITE D7.5 H10 IMPLANT, RESORBABLE, FOR ARTICULAR OSTEOCHONDRAL REPAIR QRU CARTIHEAL LTD. 165 07290019087175

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention