BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 18787016 · Received February 27, 2024

    Report

    Report Number
    3020652309-2024-00001
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    September 14, 2023
    Report Date
    October 10, 2023
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    PMA / PMN Number
    DEN2000035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY OR ESTABLISH A SINGLE ROOT CAUSE FOR THE REPORTED EVENT. ARTHROFIBROSIS IS A COMMON ADVERSE EVENT ASSOCIATED WITH STANDARD ACL RECONSTRUCTION. IT IS UNKNOWN IF THE ADVERSE EVENT REPORTED BY THE PATIENT AND CONFIRMED WITH THE FOLLOW-UP PROCEDURE AT HSS WAS RELATED TO THE ORIGINAL SURGICAL PROCEDURE OR THE DEVICE ITSELF (BEAR IMPLANT). A REVIEW OF THE MANUFACTURING PROCESS RECORDS DEMONSTRATED THAT THIS DEVICE LOT, 7008155, MET ALL FINISHED DEVICE SPECIFICATIONS PRIOR TO RELEASE. THE DELAY IN REPORTING THIS ADVERSE EVENT WAS DUE TO TECHNICAL DIFFICULTIES ENCOUNTERED WHILE ENROLLING IN THE EMDR PROGRAM.

    Description of Event or Problem · 0

    PATIENT RECEIVED THE BEAR IMPLANT AS PART OF THE (B)(6) CLINICAL TRIAL (B)(4). INITIAL SURGERY WAS PERFORMED AT (B)(6) HOSPITAL BY DR. (B)(6) ON (B)(6) 2023. PATIENT SAW DR. (B)(6) FOR A FOLLOW-UP VISIT ON (B)(6) 2023. DR. (B)(6) VISIT NOTES STATE THAT THE PATIENT WAS REPORTING CONSTANT PAIN AND CONTINUED KNEE DYSFUNCTION. MRI CONFIRMED ACL REPAIR WAS INTACT AND THAT CLUNK ON KNEE EXTENSION AND SWELLING ARE SYMPTOMS OF LOCALIZED ARTHROFIBROSIS AND/OR CYCLOPS LESION. DR. (B)(6) RECOMMENDED DIAGNOSTIC ARTHROSCOPY FOR EVALUATION OF PATIENT'S ACL AND ARTICULAR SURFACES, WITH ARTHROSCOPIC AND POSSIBLE RELEASE OF ADHESIONS, CYCLOPS LESION, AND DEBRIDEMENT. PATIENT REPORTED THAT SECOND OPINION RECOMMENDED REMOVAL OF HIS ACL AND REVISION RECONTRUCTION IN ONE SETTING. PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE AT HOSPITAL FOR SPECIAL SURGERY (HSS) IN (B)(6) ON (B)(6)2023. THE PROCEDURE CONSISTED OF KNEE ARTHROSCOPY FOR DEBRIDEMENT OF SCAR TISSUE AND LYSIS OF LESIONS. A LARGE AMOUNT OF NON-FUNCTIONAL SCAR TISSUE WAS REMOVED FROM THE NOTCH. TWO FIBERTAPES WERE REMOVED - ONE WAS RUPTURED AND FUNCTIONED AS A LOOSE BODY. MULTIPLE SPECIMENS WERE REMOVED FROM THE KNEE DURING THE PROCEDURE FOR PATHOLOGY ANALYSIS. SPECIMEN #1: BEAR ACL TISSUE - SPECIMEN CONSISTS OF SEVERAL PIECES OF WHITE-TAN SOFT TISSUE (GROSS DESCRIPTION); FRAGMENTS OF FIBROADIPOSE TISSUE WITH NEOVASCULARIZATION (MICROSCOPIC DESCRIPTION). SPECIMEN #2: BEAR ACL TISSUE - SPECIMEN CONSISTS OF SEVERAL PIECES OF WHITE-TAN TISSUE (GROSS); SYNOVIAL LINED FIBROUS TISSUE WITH CYSTIC CHANGE (MICROSCOPIC). SPECIMEN #3: SOFT TISSUE (KNEE) SHAVINGS - SPECIMEN IS PRESENT IN A WHITE FABRIC SAC AND CONSISTS OF MULTIPLE PIECES OF WHITE-TAN SOFT TISSUE (GROSS); FRAGMENTS OF SYNOVIUM, FIBROADIPOSE TISSUE WITH NEOVASCULARIZATION (MICROSCOPIC). SPECIMEN #4: SUTURE FROM BEAR IMPLANT PROCEDURE - SPECIMEN CONSISTS OF 3 FRAGMENTS OF SUTURE MATERIAL OF VARYING LENGTHS (GROSS); MICROSCOPIC EXAMINATION WAS NOT PERFORMED. THE PATIENT INITIALLY CALLED (B)(6) ON (B)(6) 2023. HE WAS VERY UPSET AND STATED THAT HE RECEIVED THE BEAR IMPLANT IN (B)(6) 2023 AND WAS IN PAIN AND HAVING DIFFICULTY WALKING. THE PATIENT CALLED (B)(6), (B)(6) VP OF CLINICAL OPERATIONS, ON (B)(6) 2023 AND AGAIN ON (B)(6) 2023. PATIENT SAID HE RECEIVED THE BEAR IMPLANT AS PART OF THE BEAR MOON TRIAL AND HAD DEVELOPED ARTHROFIBROSIS. HE ADDED THAT HE SOUGHT A SECOND OPINION AND HAD A FOLLOW-UP PROCEDURE AT HSS AND THAT THE SURGEON PULLED A 'MESH/CLOTH MATERIAL' FROM HIS KNEE. (B)(6) REQUESTED THE HSS REPORT AS WELL AS ANALYSIS OF THE MESH/CLOTH MATERIAL. (B)(6), (B)(6)VP OF QUALITY, SPOKE TO DR. (B)(6) ON (B)(6) 2023. ACCORDING TO DR. (B)(6), THERE WAS NOTHING NOTEWORTHY ABOUT THE PROCEDURE OR THE BEAR IMPLANT AND THAT NOTHING UNUSUAL OCCURRED DURING THE PROCEDURE; HOWEVER, HE DID STATE THE PATIENT WAS IN PAIN 'FROM THE GET GO'. DR. (B)(6) ADDED THAT THE PATIENT HAD REASONABLY GOOD MOTION PRIOR TO THE SURGERY AND THAT HE WAS COMPLIANT WITH PHYSICAL THERAPY PROGRAM FOLLOWING THE SURGERY. DR. (B)(6) SAID THE ARTHROFIBROSIS WAS DUE TO THE SURGICAL PROCEDURE AND/OR THE BEAR IMPLANT BUT COULD NOT DEFINITIVELY ATTRIBUTE ROOT CAUSE TO ONE OR THE OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120091 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT BEAR IMPLANT FOR ACL REPAIR QNI MIACH ORTHOPAEDICS 7008155

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention ETHICON #2 ETHIBOND NON-RESORBABLE SUTURE.| ETHICON #2 VICRYL RESORBABLE SUTURE.