BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP/MAGNUM ACETABULAR SHELL 48 X42MM POR SHELL COCR PC DIA48/42MM

    MDR report key: 2882196 · Received December 20, 2012

    Report

    Report Number
    3002806535-2012-00373
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    May 31, 2012
    Report Date
    March 15, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. (B)(4). MEDICAL PRODUCTS - BI-METRIC FEMORAL STEM CATALOG#: 162312 LOT#: 1463315, MAGNUM FEMORAL HEAD CATALOG#: 157442 LOT#: 1409832, MAGNUM TAPER ADAPTER CATALOG#: 139258 LOT#: 1416088. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2012-00373, 3002806535-2017-00133.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE APPROXIMATELY 4 YEARS POST-IMPLANTATION DUE TO PAIN, SWELLING, PSEUDOTUMOR FORMATION AND ELEVATED METAL ION LEVELS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA WRITTEN LIABILITY CLAIM THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY, LEFT SIDE, ON (B)(6) 2008, AND TOTAL HIP ARTHROPLASTY, RIGHT SIDE, ON (B)(6) 2008. PATIENT'S LEGAL CLAIM ALLEGES PAIN IN BOTH SIDES, SWELLING, A PSEUDOTUMOR. AND ELEVATED METAL ION LEVELS. REVISION PROCEDURE WAS PERFORMED ON THE LEFT SIDE ON (B)(6) 2012 AND REVISION FOR THE RIGHT SIDE IS RECOMMENDED. 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
    1 RECAP/MAGNUM ACETABULAR SHELL 48 X42MM POR SHELL COCR PC DIA48/42MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 1413359

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R