BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER COMPRESS HA ANTI ROTATION SPINDLE SHORT LARGE 44MM

    MDR report key: 6870119 · Received September 15, 2017

    Report

    Report Number
    0001825034-2017-07088
    Event Type
    Injury
    Date Received
    September 15, 2017
    Report Date
    October 26, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101475
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). MEDICAL PRODUCTS : CPS SHORT ANCHOR PLUG 12MM CATALOG #178554 LOT # 001020, CPS NUT CO-CR-MO ALLOY CATALOG #178512 LOT #285140, CPS CENTERING SLEEVE 23MM CATALOG #178545 LOT #694150, OSS POLY TIBIAL BUSHING CATALOG #150476 LOT #464690, OSS POLY LOCK PIN CATALOG #150478 LOT #503140, OSS POLY FEMORAL BUSHINGS 2PK CATALOG #150477 LOT #435070, CPS TRANSVERSE PIN 6PK 44MM CATALOG #178530 LOT #915110, OSS AXLE CATALOG #150480 LOT #745770, OSS REINFORCED YOKE CATALOG #150493 LOT #856000, CPS/OSS 5CM TPR ADAPT W/OSS SC CATALOG #178711 LOT #713740, OSS 7CM SEGMENTAL FEMORAL RT CATALOG #150354 LOT #234280, OSS 17CM DIAPHYSEAL SEGMENT CATALOG #150471 LOT #630000, OSS TIBIAL POLY BEARING 14MM CATALOG #150411 LOT #596900. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED,A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO PATIENT BONE FRACTURE THAT LED TO LOOSENING OF THE SPINDLE, BUT IT IS UNKNOWN WHAT CAUSED THE BONE FRACTURE. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL SURGERY AND SUBSEQUENTLY UNDERWENT REVISION SURGERY DUE TO LOOSENING. THE DISTAL FEMORAL COMPRESS COMPONENT FAILED AND WAS REVISED TO TOTAL FEMUR WITH BIPOLAR HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME

    Description of Event or Problem · 1

    FURTHER INFORMATION REPORTED THAT THE PATIENT'S IMPLANTS LOOSENED SECONDARY TO BONE FRACTURE. IT IS UNKNOWN WHAT CAUSED THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650866 ZIMMER COMPRESS HA ANTI ROTATION SPINDLE SHORT LARGE 44MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 699320

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R