BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECAP SHELL COCR PC 48/42MM

    MDR report key: 3893768 · Received June 25, 2014

    Report

    Report Number
    3002806535-2014-00156
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 16, 2014
    Report Date
    November 11, 2015
    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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PRODUCT WAS RETURNED TO ZIMMER BIOMET; HOWEVER, PRODUCT WAS EVALUATED BY AN EXTERNAL SITE. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. ROOT CAUSE OF THE EVENT WAS MOST LIKELY ATTRIBUTED TO THIRD PARTY DEBRIS, PATIENT ANATOMY OR SURGICAL TECHNIQUE; HOWEVER, A CONCLUSIVE DETERMINATION COULD NOT BE MADE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 8 STATES, "DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS." NUMBER 10 STATES, "FRETTING AND CREVICE CORROSION CAN OCCUR AT INTERFACES BETWEEN COMPONENTS." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." UNDER WARNINGS AND PRECAUTIONS, NUMBER 3 STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." NUMBER 4 STATES, "MALALIGNMENT OF COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 3002806535-2014-00156 / 00157 & 3002806535-2015-04083).

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THIS IS 1 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. ALSO SEE: 3002806535-2014-00157.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2006 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO A MECHANICAL COMPLICATION OF INTERNAL JOINT PROSTHESIS AND WEAR. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2006 AND SUBSEQUENTLY WAS REVISED ON (B)(6) 2014 DUE TO A MECHANICAL COMPLICATION OF INTERNAL JOINT PROSTHESIS AND WEAR. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO REMOVE THE TAPER ADAPTER FROM THE STEM. THEREFORE, THE STEM HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370069 RECAP SHELL COCR PC 48/42MM PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 843384

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R