BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP ACETABULAR SHELL

    MDR report key: 1970161 · Received January 14, 2011

    Report

    Report Number
    3005180920-2010-00027
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 27, 2010
    Report Date
    January 11, 2011
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    PMA / PMN Number
    K083116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: VERSAFITCUP DOUBLE MOBILITY ACETABULAR SHELL - REF (B)(4)/LOT 101931. THE QUALITY AND MANUFACTURING DOCUMENTS OF THE ACETABULAR SHELL LOT 101931 (B)(4) HAVE BEEN REVIEWED: ALL THE VALUES WERE FOUND TO BE CONFORMING TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. (B)(4). THE BATCH RECORDS OF THE CORRELATED PIECES WERE ALSO CHECKED: (B)(4). WITHOUT FINDING ANY ANOMALY OR NOT CONFORMING VALUES IN BOTH THE BATCH RECORDS. STATISTICS: ALL THE EVENTS INVOLVING VERSAFITCUP ACETABULAR SHELL NOTIFIED AS COMPLAINTS WERE REVIEWED. THE FAILURE OF PRESS FIT OCCURRED THREE TIME IN 2010, (B)(4), NO SIMILAR EVENTS ON THE SAME ISSUE WERE REPORTED IN THE PAST. THE THREE EVENTS INVOLVE THREE DIFFERENT LOTS OF ACETABULAR SHELLS AND THE PROBLEM OCCURRED TWICE TO DOCTOR (B)(6) AND ONCE TO DOCTOR (B)(6), BOTH IN THE USA. NO OTHER SURGEONS NOTIFIED THE INSTABILITY OF MEDACTA'S METAL BACKS SO FAR. FOR THIS REASON, THE FAILURE OF PRESS FIT IS LIKELY TO BE ASSOCIATED WITH THE REAMING TECHNIQUE AND THE EVENT IS THOUGHT TO BE NOT DEVICE RELATED.

    Description of Event or Problem · 1

    DURING THE SURGERY, DR. (B)(6) REAMED UP TO 58MM AND IMPACTED A SIZE 58MM CUP. AFTER PREPARING THE FEMUR, HE IMPLANTED ALL THE IMPLANTS AND PERFORMED HIS FINAL REDUCTION BEFORE CLOSING. AFTER REDUCTION, HE MENTIONED THAT THE HIP FELT STABLE BUT HE THOUGHT THE CUP HAD MOVED. HE THEN REMOVED THE HEAD, LINER AND STEM IN ORDER TO FURTHER INSPECT THE CUP. UPON FURTHER INSPECTION, HE NOTICED THAT THE CUP HAD MIGRATED AND LOOSENED. HE THEN SWITCHED TO ORTHO DEVELOPMENT TRI-PLUS SYSTEM (CLEARED TO BE USED WITH MEDACTA TOTAL HIP SYSTEM) AND IMPACTED A SIZE 60MM ORTHO DEVELOPMENT CUP WITH SCREWS FOR BETTER FIXATION. HE THEN FINISHED THE CASE WITH NO FURTHER ISSUES PERTAINING TO THIS MATTER. ON (B)(6) 2010, CONFIRMATION WAS RECEIVED THAT THERE WAS A 7 MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAFITCUP ACETABULAR SHELL ACETABULAR SHELL MEH MEDACTA INTERNATIONAL SA 101931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention MECTACER FEM BALL HEAD - REF (B)(4)| LOT 091990| LOT 092372| VERSAFITCUP DM HC LINER - REF (B)(4)