BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 48/42MM

    MDR report key: 3052646 · Received April 11, 2013

    Report

    Report Number
    3002806535-2013-00057
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2012
    Report Date
    July 22, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS BEING FILED REGARDING ADDITIONAL INFORMATION THAT WAS RECEIVED ON JULY 22, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNCIL THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 ALLEGEDLY DUE TO ALVAL. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. FURTHER INFORMATION RECEIVED (B)(6) 2014: AFTER PRIMARY SURGERY, THE PAIN WAS GONE, BUT PATIENT EXPERIENCED A SHARP JABBING SENSATION AND DEVELOPED INCREASING PAIN OVER TIME. PATIENT UNDERWENT REVISION ON MARCH 27, 2012 AT THE ROYAL NATIONAL ORTHOPEDIC HOSPITAL DUE TO PAIN. DURING THE REVISION A SMALL CRACK IN GREATER TROCHANTER WAS NOTICED AND DURING THE REAMING PROCESS, A FREE FRACTURE OF THE GREATER TROCHANTER OCCURRED. ACCORDING TO THE SURGEON, THE APPEARANCE AT SURGERY SUGGESTED ARMD/ALVAL. SAMPLES TAKEN DURING REVISION WERE SENT FOR HISTOPATHOLOGICAL ANALYSIS; ARMD IS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY PATIENT'S LEGAL COUNCIL THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 ALLEGEDLY DUE TO ALVAL. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156799 RECAP SHELL COCR PC 48/42MM RECAP/MAGNUM SHELL KWA BIOMET UK LTD. N/A 1094650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R