BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 20463881 · Received October 16, 2024

    Report

    Report Number
    3020652-2024-00002
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 16, 2024
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    UDI-DI
    00860002987804
    PMA / PMN Number
    DEN200035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY OR ESTABLISH A SINGLE ROOT CAUSE FOR THE REPORTED EVENT. IN ADDITION, WHERE AS THE BLISTERING AND WEEPING ON THE KNEE WAS TOPICAL AND NOT INTERNAL COULD BE INDICATIVE OF A TOPICAL REACTION AND NOT AN ALLERGIC REACTION INTERNALLY.

    Description of Event or Problem · 0

    SURGEON CONTACTED A MIACH SALES REPRESENTATIVE REGARDING A 17 YEAR OLD FEMALE PATIENT WITH A POSSIBLE ALLERGIC REACTION (OR REJECTION) TO THE BEAR IMPLANT ON (B)(6) 2024. THE BEAR IMPLANT SURGERY WAS COMPLETED ON (B)(6) 2023. THE SURGEON STATES THAT THE PATIENT HAD BLISTERING AND WEEPING AROUND THE KNEE IN THE FIRST 3 OR 4 MONTHS POSTOP. THE KNEE WAS TAPPED MULTIPLE TIMES, WAS NOT INFECTED, AND C. ACNES WAS RULED OUT. THE ISSUE SETTLED DOWN AND THE PATIENT COMPLETED HER REHAB. WHEN SHE RETURNED TO SPORT, SHE RE-TORE HER ACL DURING HER FIRST VOLLEYBALL PRACTICE AT 1 YEAR POSTOP. THE SURGEON REVISED HER KNEE TO A QUAD TENDON AUTOLOGOUS GRAFT (ACL RECONSTRUCTION), AND HE COMMENTED THAT "THERE WAS BASICALLY NO ACL TISSUE" PRESENT IN THE KNEE AT THE TIME OF THE REVISION SURGERY. THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL DETAILS: "SHE DOESN'T HAVE ANY ALLERGIES (TO BEEF OR ANYTHING ELSE). SHE HAD SKIN NECROSIS ALONG ALL THE INCISIONS, FRACTURE-TYPE BLISTERS, A TON OF STIFFNESS (NEVER HAD TO HAVE A MANIP BUT CAME CLOSE). A BIG ESCHAR FORMED OVER THE DISTAL MEDIAL INCISION WHERE THE INTERNAL BRACE SUTURES COME OUT AND THEN GET ANCHORED DOWN TO THE TIBIA. BUT ALL THE INCISIONS LOOKED BAD/WEEPY. YOU CAN SEE THE FIRST POSTOP PICS FROM 2 WEEKS POSTOP IN ONE OF THE PHOTOS. THEN THE OTHER PICS SHOW THE SAME INCISIONS LATER AS THEY HEALED. WE TAPPED HER KNEE 2 WEEKS OUT FROM SURGERY BUT IT WAS VERY BENIGN (3300 WBC, 20K RBC IN THE JOINT FLUID, CULTURES NEVER GREW ANYTHING). WE THOUGHT AT THE TIME IT COULD POSSIBLY HAVE BEEN A REACTION TO VICRYL SUTURE, BUT I SERIOUSLY DOUBT THAT WAS IT BECAUSE SHE HAD A QUAD TENDON ACL RECON ON THE OTHER KNEE THE YEAR BEFORE, AND I CLOSE EVERY QUAD TENDON HARVEST WITH AN 0-VICRYL. AND THERE WAS NO REACTION FROM THAT. OTHER POSSIBILITY WOULD BE THE STERI-STRIPS-- WE HAD CHANGED PRODUCTS FROM THOSE BETWEEN HER TWO OPERATIONS. BUT IF THAT WERE THE CASE I WOULDN'T HAVE EXPECTED ANY JOINT STIFFNESS, AND CERTAINLY YOU WOULDN'T EXPECT THAT TO CAUSE THE FAILURE OF THE ACL AS SOON AS SHE WENT BACK TO SPORT. SHE UNDERWENT AN ACL RECON 3 MONTHS AGO AND IS DOING GREAT FROM THAT, NO ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568298 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT BEAR IMPLANT QNI MIACH ORTHOPAEDICS 7009197 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Other