BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD SSK DIRECT COMPRESSION MOLDED POLYETHYLENE CONSTRAINED TIBIAL BEARING 1

    MDR report key: 6024556 · Received October 12, 2016

    Report

    Report Number
    0001825034-2016-04017
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    September 8, 2016
    Report Date
    February 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK042757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. CONCOMITANT PRODUCTS: BIOMET KNEE STEM CATALOG 148182 LOT 619680; BIOMET KNEE STEM CATALOG 148244 LOT 842690; VANGUARD POSTERIOR FEMORAL AUGMENT CATALOG 184146 LOT 800260; BIOMET TIBIAL TRAY CATALOG 141743 LOT 057300; BIOMET OFFSET TIBIAL TRAY 141490 LOT 464540; VANGUARD POSTERIOR FEMORAL AUGMENT CATALOG 184166 LOT 520070; BIOMET TIBIAL OFFSET; COBALT BONE CEMENT CATALOG 402282 LOT 604900; VANGUARD SSK FEMORAL 70MM CATALOG 183326 LOT 806520.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 15 STATES, "INTEROPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED TIBIAL BEARING. THE CONDYLES HAVE MULTIPLE DIVOTS WHICH THE SALES REP WAS LIKELY REFERENCING, THUS THE COMPLAINT IS CONFIRMED. THE POST HAS MULTIPLE LOCATIONS OF DAMAGE. THE TOP LATERAL CORNER OF THE POST HAS BEEN FLATTENED AND THE LOWER MEDIAL SIDE OF THE POST HAS DAMAGE. THE DAMAGE IS TOO SUBSTANTIAL TO BE FROM EXPLANTATION, AND NON-UNIFORM TO BE CONTINUOUS ABRASION FROM THE FEMORAL COMPONENT. IT IS LIKELY FROM THE FEMORAL COMPONENT IMPACTING THE BEARING DUE TO THE PATIENT FALL AS WAS STATED BY THE SALES REP.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT PRODUCTS: BIOMET KNEE STEM CATALOG 148182 LOT 619680; BIOMET KNEE STEM CATALOG 148244 LOT 842690; VANGUARD POSTERIOR FEMORAL AUGMENT CATALOG 184146 LOT 800260; BIOMET TIBIAL TRAY CATALOG 141743 LOT 057300; BIOMET OFFSET TIBIAL TRAY 141490 LOT 464540; VANGUARD POSTERIOR FEMORAL AUGMENT CATALOG 184166 LOT 520070; BIOMET TIBIAL OFFSETCATALOG 141483 LOT 727640.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A LEFT KNEE REVISION PROCEDURE APPROXIMATELY FOUR MONTHS POST IMPLANTATION DUE TO PAIN AFTER A FALL. THE TIBIAL BEARING AND LOCKING BAR WERE REMOVED AND REPLACED. UNDEFINED MARKINGS ON THE BEARING WERE NOTED DURING THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674726 VANGUARD SSK DIRECT COMPRESSION MOLDED POLYETHYLENE CONSTRAINED TIBIAL BEARING 1 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 282380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R