BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR -3MM NECK

    MDR report key: 7423062 · Received April 11, 2018

    Report

    Report Number
    0001825034-2018-02527
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE IMPLANTED IN 2002. CONCOMITANT MEDICAL PRODUCTS: ITEM# UNKNOWN STEM UNKNOWN LOT #. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2018 - 02528.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: 105934 RNGLC LNR 32MM 10 DEG 24 514710; 163668 32MM MOD HEAD COCR - 3MM NECK 036550; 14-103656 UNIV 2-HOLE SHL 56MM LNR SZ 24 784040; 162629 BI-METRIC POR FMRL-C 14X150MM 185450; 103532 TI LOW PROFILE SCREW 6.5X25MM 889480. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAY REVIEW STATES CP POSITION IN THE RIGHT FEMORAL HEAD MOST CONSISTENT WITH POLYETHYLENE WEAR. NO DISLOCATION ALTHOUGH THERE IS PARTIAL UNCOVERING OF BOTH FEMORAL HEADS WITHOUT FRANK DISLOCATION. THIS LIKELY CONTRIBUTE TO THE PATIENT'S DISLOCATION. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. 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 A PATIENT WAS SCHEDULED FOR HIP REVISION APPROXIMATELY 16 YEARS POST-IMPLANTATION DUE TO DISLOCATION AND POLY LINER WEAR. THE REVISION WAS CANCELLED FOR UNKNOWN REASONS. ADDITIONAL INFORMATION REQUESTED AND RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264224 32MM MOD HEAD COCR -3MM NECK HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 036550

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other