BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE

    MDR report key: 6143131 · Received December 2, 2016

    Report

    Report Number
    0001825034-2016-05030
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    November 3, 2016
    Report Date
    April 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: OSS POLY BUMPER LOCK PIN: CATALOG 150510, LOT 014090. OSS REINFORCED YOKE: CATALOG 150493, LOT 220000. TIBIAL BEARING 20MM STANDARD ARCOM: CATALOG 150414, LOT 093360. RS FEMORAL BUSHINGS SET ARCOM: CATALOG 161034, LOT 648910. OSS RS AXLE: CATALOG 161035, LOT 373600. TIBIAL BUSHING ARCOM: CATALOG 150476, LOT 324660. PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE IS USED FOR TREATMENT. THE COMPLAINT COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE.

    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. (B)(4). CONCOMITANT PRODUCTS: TIBIAL BEARING 20MM STANDARD ARCOM CATALOG 150414 LOT 093360; RS FEMORAL BUSHINGS SET ARCOM CATALOG 161034 LOT 648910; TIBIAL BUSHING ARCOM CATALOG 150476 LOT 324660. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, ¿FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT." THIS REPORT IS NUMBER 8 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-05023 / 1825034-2016-05030).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF PICTURE PROVIDED CONFIRMS THE REPORTED EVENT AS THE YOKE IS FRACTURED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    DURING A KNEE ARTHROPLASTY, IT WAS NOTED THAT THE YOKE AND BUMPER LOCKING PIN WERE FRACTURED. ALL COMPONENTS AND FRAGMENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791888 ORTHOPEDIC SALVAGE SYSTEM (OSS) YOKE PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 220000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R