BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR FEMORAL BALL HEAD Ø 32 S

    MDR report key: 5104174 · Received September 25, 2015

    Report

    Report Number
    3005180920-2015-00210
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 28, 2015
    Report Date
    December 22, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K072857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 23 NOV 2015 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 25 NOV 2015 IT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 SEPTEMBER 2015: LOT 148644: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. VERSAFITCUP CC FLAT PE HC LINER Ø 32 / E REF. 01.26.3244HCT LOT. 151087 (K103352): LOT 151087: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. AMISTEM H CEMENTLESS STD STEM #3 REF. 01.18.133 LOT. 150849 (K093944): LOT 150849: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED ISSUE. ON 07 SEPTEMBER 2015 IT WAS ADDED THAT: THE EXPLANTED IMPLANTS WERE SENT TO A LABORATORY AND ARE NOT AVAILABLE YET. ACCORDING TO THE SURGEON, THERE WAS ONLY A CUTANEOUS INFECTION AND NO INFECTION SIGNS AROUND THE IMPLANTS. ON 23.SEP.2015 IT WAS COMMUNICATED THAT THE REP. TRIED TO CALL AGAIN THE SURGEON TO GET FURTHER INFORMATION. THE INFECTION WAS CONFIRMED BUT HE DOESN'T WANT TO COMMUNICATE MORE INFORMATION ABOUT THIS PATIENT. NOT AVAILABLE YET.

    Description of Event or Problem · 1

    SUSPICION OF INFECTION. THE SURGEON DECIDED TO RE-OPEN AND CHANGE THE MOBILE ELEMENTS (HEAD AND INLAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634587 COCR FEMORAL BALL HEAD Ø 32 S FEMORAL METALLIC BALL HEAD JDI MEDACTA INTERNATIONAL SA 148644

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention