BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP PF HA FMRL HEAD RESUR 46MM

    MDR report key: 3924520 · Received July 9, 2014

    Report

    Report Number
    0001825034-2014-06039
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    October 18, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK071053
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: PATIENT WAS NOT ENROLLED IN A CLINICAL STUDY. A RETROSPECTIVE CLINICAL REVIEW IDENTIFIED THE PATIENT¿S EVENT.

    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 THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, ¿MATERIAL SENSITIVITY REACTIONS.¿ NUMBER 15 STATES, ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06038 / -06040).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH: EVENT DESCRIPTION: UPDATED TO INCLUDE FLUID COLLECTION SIZE. THIS REPORT IS NUMBER 3 OF 4 MDR'S FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-06038 / 06040 & 08595).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005. THE PATIENT ALSO HAD A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 ON THE RIGHT HIP DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND LARGE FLUID COLLECTION. IN ADDITION, METAL DEBRIS AND TISSUE REACTION WERE ALSO REPORTED. THERE IS NO INFORMATION TO SUGGEST THAT THE LEFT HIP WAS REVISED.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005. THE PATIENT ALSO HAD A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 ON THE RIGHT HIP DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND LARGE FLUID COLLECTION. IN ADDITION, METAL DEBRIS AND TISSUE REACTION WERE ALSO REPORTED. THERE IS NO INFORMATION TO SUGGEST THAT THE LEFT HIP WAS REVISED.

    Description of Event or Problem · 1

    AS PART OF A RETROSPECTIVE CLINICAL STUDY, A PATIENT WAS IDENTIFIED WHO UNDERWENT A RIGHT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2005. THE PATIENT ALSO HAD A LEFT FEMORAL RESURFACING PROCEDURE ON (B)(6) 2009. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2012 ON THE RIGHT HIP DUE TO METALLOSIS, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION MEASURING 5X7X3. IN ADDITION, METAL DEBRIS AND TISSUE REACTION WERE ALSO REPORTED. THERE IS NO INFORMATION TO SUGGEST THAT THE LEFT HIP WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401166 RECAP PF HA FMRL HEAD RESUR 46MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 580200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R